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FDA · Medical device recall

GE Healthcare Centricity Universal Viewer (UV)… and 4 more products

April 9, 2025 Class II

Date
April 9, 2025
Risk class
Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
Status
Ongoing
Filed by
GE Healthcare
Reason
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Distribution pattern
Worldwide distribution.

5 products in this recall

GE Healthcare Centricity Universal Viewer (UV)…

Product
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16) 2088026-713; 17) 2088026-714; 18) 2088026-715; 19) 2088026-723; 20) 2088026-806; 21) 2088026-906; 22) 2088026-936; 23) 2088026-940; 24) 2088026-943; 25) 2088026-946; 26) 2088026-948; 27) 2088026-957; 28) 2088026-959; 29) 2088026-960; 30) 2088026-961; 31) 2088026-962; 32) 2088026-967; 33) 2088026-969; 34) 2088026-970; 35) 2088026-971; 36) 2088026-973; 37) 2088026-985; 38) 2088026-989; 39) 2088026-990; 40) 2088026-993; 41) 2088026-994; 42) 2089629-003; 43) 2100169-001; 44) 2100491-006; 45) 2100491-012; 46) 2102675-010; 47) 2102675-101; 48) 2102676-001; 49) 2104867-001; 50) 2104867-044; 51) 2104867-045; 52) 2111141-004; 53) 5826659-002; 54) 5826659-013; 55) 5826659-014; 56) 5826659-016; 57) 5826659-017; 58) 5826659-018; 59) 5826659-019; 60) 5826659-021; 61) 5826659-022; 62) 5826659-023; 63) 5826659-025; 64) 5826659-026; 65) 5826659-027; 66) 5826659-028; 67) 5826659-029; 68) 5826659-030; 69) 5826659-032; 70) 5826659-033; 71) K1220JWED; 72) K2042VJED.
Quantity
2653 units
Codes and lots
Model/Catalog/code # 2066908-077, Installed Product ID 000346895-Centricity Universal Viewer-01804910, UDI UDI Not Required, System ID HCIT1584981UV; Model/Catalog/code # 2066908-077, Installed Product ID 3444574-Centricity Universal Viewer-19417270, UDI UDI Not Required, System ID RSMKG-SERPONG02; Model/Catalog/code # 2066908-136, Installed Product ID 280801-Centricity Universal Viewer-19737221, UDI UDI Not Required, System ID HCIT1545332UVCTRL; Model/Catalog/code # 2066908-136, Installed Product ID 651342-Centricity Universal Viewer-01365218, UDI UDI Not Required, System ID RSPBINTARO3; Model/Catalog/code # 2066908-136, Installed Product ID 265719-Centricity Universal Viewer-01455055, UDI UDI Not Required, System ID HCIT4376494UV; Model/Catalog/code # 2066908-150, Installed Product ID KE2701-DF UV 50K BASE-00394965, UDI UDI Not Required, System ID KE2701UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE0301-Centricity Universal Viewer-00116859, UDI UDI Not Required, System ID KE0301UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE4102-Centricity Universal Viewer-01402658, UDI UDI Not Required, System ID KE4102UW02; Model/Catalog/code # 2066908-150, Installed Product ID KE1701-Centricity Universal Viewer-01292401, UDI UDI Not Required, System ID KE1701UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE3502-Centricity Universal Viewer-01400662, UDI UDI Not Required, System ID KE3502UW02; Model/Catalog/code # 2066908-150, Installed Product ID 442900-Centricity Universal Viewer-01460668, UDI UDI Not Required, System ID LIFECARE4; Model/Catalog/code # 2088026-003, Installed Product ID 50567-Centricity Universal Viewer-02176369, UDI UDI Not Required, System ID HCIT4567313UV; Model/Catalog/code # 2088026-003, Installed Product ID M41726-Centricity Universal Viewer-00043700, UDI UDI Not Required, System ID M4172630 / M4172632 / M4172633; Model/Catalog/code # 2088026-003, Installed Product ID 349551-Centricity Universal Viewer-02350518, UDI UDI Not Required, System ID HCIT4433887UV; Model/Catalog/code # 2088026-026, Installed Product ID 101044-1-Centricity Universal Viewer-00558694, UDI UDI Not Required, System ID 1-103108035; Model/Catalog/code # 2088026-026, Installed Product ID 102359-1-Centricity Universal Viewer-00558696, UDI UDI Not Required, System ID 1-473998727; Model/Catalog/code # 2088026-026, Installed Product ID 10831-2-Centricity Universal Viewer-00558682, UDI UDI Not Required, System ID 1-644600677; Model/Catalog/code # 2088026-026, Installed Product ID DZ0000-Centricity Universal Viewer-00116878, UDI UDI Not Required, System ID DZ1128PP02; Model/Catalog/code # 2088026-026, Installed Product ID EG1526-Centricity Universal Viewer-00158976, UDI UDI Not Required, System ID EG1526PP01; Model/Catalog/code # 2088026-026, Installed Product ID HC0847-Centricity Universal Viewer-00260807, UDI UDI Not Required, System ID HC0847PC10; Model/Catalog/code # 2088026-026, Installed Product ID KE3602-Centricity Universal Viewer-01273354, UDI UDI Not Required, System ID KE3602UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE3901-Centricity Universal Viewer-00164433, UDI UDI Not Required, System ID KE3901UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE4001-Centricity Universal Viewer-01402660, UDI UDI Not Required, System ID KE4001UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1301-Centricity Universal Viewer-01401531, UDI UDI Not Required, System ID KE1301UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2702-Centricity Universal Viewer-01273356, UDI UDI Not Required, System ID KE2702UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0902-Centricity Universal Viewer-01402709, UDI UDI Not Required, System ID KE0902UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1101-Centricity Universal Viewer-01401557, UDI UDI Not Required, System ID KE1101UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0701-Centricity Universal Viewer-01402671, UDI UDI Not Required, System ID KE0701UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0401-Centricity Universal Viewer-01402713, UDI UDI Not Required, System ID KE0401UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0802-Centricity Universal Viewer-01402703, UDI UDI Not Required, System ID KE0802UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE0402-Centricity Universal Viewer-00545837, UDI UDI Not Required, System ID KE0402UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE4002-Centricity Universal Viewer-01402663, UDI UDI Not Required, System ID KE4002UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1402-Centricity Universal Viewer-00545752, UDI UDI Not Required, System ID KE1402UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1110-Centricity Universal Viewer-00165185, UDI UDI Not Required, System ID KE1110UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE3801-Centricity Universal Viewer-01402651, UDI UDI Not Required, System ID KE3801UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1002-Centricity Universal Viewer-01402705, UDI UDI Not Required, System ID KE1002UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1602-Centricity Universal Viewer-00398255, UDI UDI Not Required, System ID KE1602UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2401-Centricity Universal Viewer-01400343, UDI UDI Not Required, System ID KE2401UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2001-Centricity Universal Viewer-00545326, UDI UDI Not Required, System ID KE2001UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE3103-Centricity Universal Viewer-01291119, UDI UDI Not Required, System ID KE3103UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2202-Centricity Universal Viewer-00394958, UDI UDI Not Required, System ID KE2202UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE0301-Centricity Universal Viewer-00116867, UDI UDI Not Required, System ID KE0301UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2002-Centricity Universal Viewer-00436886, UDI UDI Not Required, System ID KE2002UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0202-Centricity Universal Viewer-01322800, UDI UDI Not Required, System ID KE0202UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE1801-Centricity Universal Viewer-00394962, UDI UDI Not Required, System ID KE1801UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE4705-Centricity Universal Viewer-01399134, UDI UDI Not Required, System ID KE4705UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE2502-Centricity Universal Viewer-01402717, UDI UDI Not Required, System ID KE2502UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1502-Centricity Universal Viewer-00169905, UDI UDI Not Required, System ID KE1502UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE0201-Centricity Universal Viewer-00505900, UDI UDI Not Required, System ID KE0201UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE0501-Centricity Universal Viewer-01287033, UDI UDI Not Required, System ID KE0501UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0502-Centricity Universal Viewer-01402710, UDI UDI Not Required, System ID KE0502UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2302-Centricity Universal Viewer-00392294, UDI UDI Not Required, System ID KE2302UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2301-Centricity Universal Viewer-01295627, UDI UDI Not Required, System ID KE2301UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1601-Centricity Universal Viewer-00115267, UDI UDI Not Required, System ID KE1602UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE1702-Centricity Universal Viewer-01292405, UDI UDI Not Required, System ID KE1702UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0302-Centricity Universal Viewer-00116868, UDI UDI Not Required, System ID KE0302UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE0901-Centricity Universal Viewer-01402707, UDI UDI Not Required, System ID KE0901UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2102-Centricity Universal Viewer-00165188, UDI UDI Not Required, System ID KE2102UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1302-Centricity Universal Viewer-01273351, UDI UDI Not Required, System ID KE1302UW01; Model/Catalog/code # 2088026-026, Installed Product ID KE1001-Centricity Universal Viewer-01284006, UDI UDI Not Required, System ID KE1111UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE0702-Centricity Universal Viewer-01402674, UDI UDI Not Required, System ID KE0702UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1202-Centricity Universal Viewer-01401517, UDI UDI Not Required, System ID KE1202UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE1201-Centricity Universal Viewer-01292408, UDI UDI Not Required, System ID KE1201UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE4402-Centricity Universal Viewer-00394722, UDI UDI Not Required, System ID KE4402UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE0102-Centricity Universal Viewer-01295540, UDI UDI Not Required, System ID KE0102UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1902-Centricity Universal Viewer-01401503, UDI UDI Not Required, System ID KE1902UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2101-Centricity Universal Viewer-00436851, UDI UDI Not Required, System ID KE2101UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1501-Centricity Universal Viewer-00545696, UDI UDI Not Required, System ID KE1501UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE3601-Centricity Universal Viewer-01401565, UDI UDI Not Required, System ID KE3601UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE4701-Centricity Universal Viewer-00115270, UDI UDI Not Required, System ID KE4701UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE2902-Centricity Universal Viewer-00347434, UDI UDI Not Required, System ID KE2902UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2202-Centricity Universal Viewer-01399132-> Name changed to KE4702-Centricity Universal Viewer-01399132, UDI UDI Not Required, System ID KE4702UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2901-Centricity Universal Viewer-01399139, UDI UDI Not Required, System ID KE2901UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2601-Centricity Universal Viewer-01400340, UDI UDI Not Required, System ID KE2601UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE4704-Centricity Universal Viewer-01273348, UDI UDI Not Required, System ID KE4704UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE3004-Centricity Universal Viewer-00598261, UDI UDI Not Required, System ID KE3004UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE4601-Centricity Universal Viewer-01402668, UDI UDI Not Required, System ID KE4601UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE1901-Centricity Universal Viewer-00545839, UDI UDI Not Required, System ID KE1901UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE1802-Centricity Universal Viewer-00398208, UDI UDI Not Required, System ID KE1802UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2501-Centricity Universal Viewer-01402715, UDI UDI Not Required, System ID KE2501UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE4101-Centricity Universal Viewer-01402655, UDI UDI Not Required, System ID KE4101UV01; Model/Catalog/code # 2088026-026, Installed Product ID KE0602-Centricity Universal Viewer-00116866, UDI UDI Not Required, System ID KE0602UW02; Model/Catalog/code # 2088026-026, Installed Product ID KE2201-Centricity Universal…
Recall started
Feb. 19, 2025
Device type
System, Image Processing, Radiological
Root cause (FDA)
Software design
What the company told customers
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification. Please ensure you have implemented the actions below: 1: Ensure your hospital network is secure and 2: Outside of the hospital network implement additional safeguards such as a VPN. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.85480@gehealthcare.com." "If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
Recall number
Z-1483-2025

GE Healthcare Centricity PACS-IW (PACS-IW)…

Product
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
Quantity
82 units
Codes and lots
Model/Catalog/Code # 2042988-001, Installed Product ID 707509-Centricity PACS-IW-01452391, UDI UDI Not Required, System ID HCIT4250187IW; Model/Catalog/Code # 2042988-001, Installed Product ID 613493-Centricity PACS-IW-02292544, UDI UDI Not Required, System ID HCIT4507688PACS; Model/Catalog/Code # 2049587-009, Installed Product ID 4276-1-Centricity PACS-IW-00558274, UDI UDI Not Required, System ID PACS-IW-168; Model/Catalog/Code # 2049587-011, Installed Product ID 12830-1-Centricity PACS-IW-00558312, UDI UDI Not Required, System ID PACS-IW-477; Model/Catalog/Code # 2049587-011, Installed Product ID 4352-1-Centricity PACS-IW-00558316, UDI UDI Not Required, System ID PACS-IW-89; Model/Catalog/Code # 2049587-012, Installed Product ID 100858-1-Centricity PACS-IW-00558426, UDI UDI Not Required, System ID PACS-IW-412; Model/Catalog/Code # 2049587-012, Installed Product ID 4294-1-Centricity PACS-IW-00558379, UDI UDI Not Required, System ID PACS-IW-304; Model/Catalog/Code # 2049587-012, Installed Product ID 13039-1-Centricity PACS-IW-00558385, UDI UDI Not Required, System ID PACS-IW-313; Model/Catalog/Code # 2049587-012, Installed Product ID 4744-1-Centricity PACS-IW-00558373, UDI UDI Not Required, System ID PACS-IW-444; Model/Catalog/Code # 2049587-012, Installed Product ID 101216-1-Centricity PACS-IW-00558356, UDI UDI Not Required, System ID PACS-IW-544; Model/Catalog/Code # 2049587-012, Installed Product ID 4361-1-Centricity PACS-IW-00558343, UDI UDI Not Required, System ID PACS-IW-240; Model/Catalog/Code # 2049587-012, Installed Product ID 4393-1-Centricity PACS-IW-00558328, UDI UDI Not Required, System ID PACS-IW-96; Model/Catalog/Code # 2049587-012, Installed Product ID 4573-1-Centricity PACS-IW-00558420, UDI UDI Not Required, System ID PACS-IW-114; Model/Catalog/Code # 2049587-012, Installed Product ID 4506-1-Centricity PACS-IW-00558345, UDI UDI Not Required, System ID PACS-IW-572; Model/Catalog/Code # 2049587-012, Installed Product ID AZ4030-Centricity PACS-IW-02336621, UDI UDI Not Required, System ID AZ4030PC01; Model/Catalog/Code # 2049587-012, Installed Product ID 324462-Centricity PACS-IW-01431554, UDI UDI Not Required, System ID HCIT4114037PIW; Model/Catalog/Code # 2049587-012, Installed Product ID 280801-Centricity PACS-IW-01431490, UDI UDI Not Required, System ID HCIT4096486IW; Model/Catalog/Code # 2049587-012, Installed Product ID 307319-Centricity PACS-IW-01444609, UDI UDI Not Required, System ID 2919183PACSIW; Model/Catalog/Code # 2049587-012, Installed Product ID KW1112-Centricity PACS-IW-00168151, UDI UDI Not Required, System ID KW1112PC01; Model/Catalog/Code # 2049587-015, Installed Product ID X9003074 - RMUE01-Centricity PACS-IW-00001801, UDI UDI Not Required, System ID RMUE01PC01; Model/Catalog/Code # 2049587-015, Installed Product ID KW1018-Centricity PACS-IW-01422962, UDI UDI Not Required, System ID KW1018PC01; Model/Catalog/Code # 2049587-015, Installed Product ID KW1001-Centricity PACS-IW-00164288, UDI UDI Not Required, System ID KW1001PC02; Model/Catalog/Code # 2049587-015, Installed Product ID KW1019-Centricity PACS-IW-00115173, UDI UDI Not Required, System ID KW1019PC01; Model/Catalog/Code # 2049587-015, Installed Product ID PL2997-Centricity PACS-IW-00038793, UDI UDI Not Required, System ID PL2997RW01; Model/Catalog/Code # 2049587-015, Installed Product ID PL1822-Centricity PACS-IW-00038825, UDI UDI Not Required, System ID PL1822RW02; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273193, UDI UDI Not Required, System ID RU1016ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1241-Centricity PACS-IW-01273216, UDI UDI Not Required, System ID RU1241RW01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1493-Centricity PACS-IW-01273220, UDI UDI Not Required, System ID RU1493ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273244, UDI UDI Not Required, System ID RU2967RW01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2420-Centricity PACS-IW-01273234, UDI UDI Not Required, System ID RU2420ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3262-Centricity PACS-IW-01273245, UDI UDI Not Required, System ID RU3262ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8052-Centricity PACS-IW-02337508, UDI UDI Not Required, System ID RU8052ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU6248-Centricity PACS-IW-01273279, UDI UDI Not Required, System ID RU6248ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8071-Centricity PACS-IW-01273295, UDI UDI Not Required, System ID RU8071ID01; Model/Catalog/Code # 2049587-015, Installed Product ID -Centricity PACS-IW-01273233, UDI UDI Not Required, System ID RU2371ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3880-Centricity PACS-IW-01273266, UDI UDI Not Required, System ID RU3880ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7576-Centricity PACS-IW-01273287, UDI UDI Not Required, System ID RU7576ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2527-Centricity PACS-IW-01273235, UDI UDI Not Required, System ID RU2527ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2878-Centricity PACS-IW-01273243, UDI UDI Not Required, System ID RU2878ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273306, UDI UDI Not Required, System ID RU8370ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273258, UDI UDI Not Required, System ID RU3625ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1469-Centricity PACS-IW-01273219, UDI UDI Not Required, System ID RU1469ID01; Model/Catalog/Code # 2049587-015, Installed Product ID 16757644-Centricity PACS-IW-01273200, UDI UDI Not Required, System ID RU1095ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1279-Centricity PACS-IW-02337628, UDI UDI Not Required, System ID RU1279RW03; Model/Catalog/Code # 2049587-015, Installed Product ID RU8321-Centricity PACS-IW-01273303, UDI UDI Not Required, System ID RU8321ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1130-Centricity PACS-IW-01273210, UDI UDI Not Required, System ID RU1130ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273262, UDI UDI Not Required, System ID RU3828ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273224, UDI UDI Not Required, System ID RU1669ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8953-Centricity PACS-IW-01273311, UDI UDI Not Required, System ID RU8953ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU2367-Centricity PACS-IW-01273232, UDI UDI Not Required, System ID RU2367ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1026-Centricity PACS-IW-01273195, UDI UDI Not Required, System ID RU1026ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8036-Centricity PACS-IW-01273293, UDI UDI Not Required, System ID RU8036ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7564-Centricity PACS-IW-01273286, UDI UDI Not Required, System ID RU7564ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3476-Centricity PACS-IW-01273251, UDI UDI Not Required, System ID RU3476ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3610-Centricity PACS-IW-01273257, UDI UDI Not Required, System ID RU3610ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1028-Centricity PACS-IW-01273197, UDI UDI Not Required, System ID RU1028ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU1022-Centricity PACS-IW-01273194, UDI UDI Not Required, System ID RU1022ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU5442-Centricity PACS-IW-01273277, UDI UDI Not Required, System ID RU5442ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3883-Centricity PACS-IW-01273267, UDI UDI Not Required, System ID RU3883ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3467-Centricity PACS-IW-01273250, UDI UDI Not Required, System ID RU3467ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU3663-Centricity PACS-IW-01273259, UDI UDI Not Required, System ID RU3663ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU7905-Centricity PACS-IW-01273291, UDI UDI Not Required, System ID RU7905ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273256, UDI UDI Not Required, System ID RU3593ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273218, UDI UDI Not Required, System ID RU1298ID01; Model/Catalog/Code # 2049587-015, Installed Product ID TBD-Centricity PACS-IW-01273296, UDI UDI Not Required, System ID RU8151ID01; Model/Catalog/Code # 2049587-015, Installed Product ID RU8607-Centricity PACS-IW-01273308, UDI UDI Not Required, System ID RU8607ID01; Model/Catalog/Code # 2049588-012 , Installed Product ID 4345-1-Centricity PACS-IW-00558548, UDI UDI Not Required, System ID PACS-IW-17; Model/Catalog/Code # 2049588-012 , Installed Product ID 101792-1-Centricity PACS-IW-00558370, UDI UDI Not Required, System ID DRMC00558370; Model/Catalog/Code # 2049588-012 , Installed Product ID 4378-1-Centricity PACS-IW-00558498, UDI UDI Not Required, System ID PACS-IW-445; Model/Catalog/Code # 2049588-012 , Installed Product ID 100663-1-Centricity PACS-IW-00558514, UDI UDI Not Required, System ID 1-125580707; Model/Catalog/Code # 2049588-012 , Installed Product ID 100702-1-Centricity PACS-IW-00558539, UDI UDI Not Required, System ID PACS-IW-152; Model/Catalog/Code # 2049588-012 , Installed Product ID 101625-1-Centricity PACS-IW-00558531, UDI UDI Not Required, System ID 1-271709371; Model/Catalog/Code # 2049588-012 , Installed Product ID 4593-1-Centricity PACS-IW-00558488, UDI UDI Not Required, System ID PACS-IW-147; Model/Catalog/Code # 2049588-012 , Installed Product ID 100009-1-Centricity PACS-IW-00558560, UDI UDI Not Required, System ID PACS-IW-549; Model/Catalog/Code # 2049588-012 , Installed Product ID 100838-1-Centricity PACS-IW-00558532, UDI UDI Not Required, System ID PACS-IW-153; Model/Catalog/Code # 2049588-012 , Installed Product ID 4694-1-Centricity PACS-IW-00558556, UDI UDI Not Required, System ID PACS-IW-141; Model/Catalog/Code # 2049588-012 , Installed Product ID 4358-1-Centricity PACS-IW-00558564, UDI UDI Not Required, System ID PACS-IW-418; Model/Catalog/Code # 2049588-012 , Installed Product ID 13095-1-Centricity PACS-IW-00558534, UDI UDI Not Required, System ID PACS-IW-46; Model/Catalog/Code # 2049588-012 , Installed Product ID 4301-1-Centricity PACS-IW-00558525, UDI UDI Not Required, System ID PACS-IW-355; Model/Catalog/Code # 2049588-012 , Installed Product ID 4383-1-Centricity PACS-IW-00558533, UDI UDI Not Required, System ID PACS-IW-484; Model/Catalog/Code # 2049588-012 , Installed Product ID 319674-Centricity PACS-IW-01431535, UDI UDI Not Required, System ID HCIT2882349PW03; Model/Catalog/Code # 2052829-001, Installed Product ID 4300-1-Centricity PACS-IW-00558207, UDI UDI Not Required, System ID PACS-IW-340.
Recall started
Feb. 19, 2025
Device type
System, Image Processing, Radiological
Root cause (FDA)
Software design
What the company told customers
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification. Please ensure you have implemented the actions below: 1: Ensure your hospital network is secure and 2: Outside of the hospital network implement additional safeguards such as a VPN. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.85480@gehealthcare.com." "If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
Recall number
Z-1484-2025

GE Healthcare Centricity Radiology RA600 (RA600)…

Product
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.
Quantity
1563 units
Codes and lots
Model/Catalog/Code # 2022296-001, Installed Product ID 103889-1-Centricity RA600-01461073, UDI UDI Not Required, System ID NDMGRA01; Model/Catalog/Code # 2022296-001, Installed Product ID AH5045-Centricity RA600-00000127, UDI UDI not required, System ID AH5045RW01; Model/Catalog/Code # 2022296-001, Installed Product ID AP0701-Centricity RA600-00000173, UDI UDI not required, System ID AP0701RW01; Model/Catalog/Code # 2022296-001, Installed Product ID 50451-Centricity RA600-02351785, UDI UDI Not Required, System ID HCIT1169080RA600; Model/Catalog/Code # 2022296-001, Installed Product ID 519926-Centricity RA600-00000672, UDI UDI Not required, System ID 519926RW01; Model/Catalog/Code # 2022296-001, Installed Product ID A51043-Centricity RA600-00040985, UDI UDI Not required, System ID A51043117; Model/Catalog/Code # 2022296-001, Installed Product ID 549858-Centricity RA600-01286184, UDI UDI Not Required, System ID MJ1; Model/Catalog/Code # 2022296-001, Installed Product ID RW602-Centricity RA600-00005819, UDI UDI not required, System ID RW60200083; Model/Catalog/Code # 2022296-001, Installed Product ID 80115-Centricity RA600-00005736, UDI UDI not required, System ID 60115TRS01; Model/Catalog/Code # 2033901-001, Installed Product ID 103634-5-Centricity RA600-00099545, UDI UDI Not Required, System ID 520784RA6CLSW3; Model/Catalog/Code # 2033901-001, Installed Product ID 104027-1-Centricity RA600-00102852, UDI UDI Not Required, System ID 928729RA600SW2; Model/Catalog/Code # 2033901-001, Installed Product ID 103937-1-Centricity RA600-00096217, UDI UDI not required, System ID 209386RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 103516-1-Centricity RA600-00101152, UDI UDI Not Required, System ID 661633RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 4048-6-Centricity RA600-00105916, UDI UDI not required, System ID 818901RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-48-Centricity RA600-00098944, UDI UDI not required, System ID 502555RWSW71; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-46-Centricity RA600-00098943, UDI UDI not required, System ID 502555RWSW70; Model/Catalog/Code # 2033901-001, Installed Product ID 103517-1-Centricity RA600-00108671, UDI UDI Not Required, System ID LBMEMRAREVSW; Model/Catalog/Code # 2033901-001, Installed Product ID 104157-2-Centricity RA600-01292140, UDI UDI Not Required, System ID 818345RA6SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 101711-1-Centricity RA600-00105914, UDI UDI not required, System ID 818881RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 3748-2-Centricity RA600-00105984, UDI UDI Not Required, System ID 831624RA600SW3; Model/Catalog/Code # 2033901-001, Installed Product ID 103447-1-Centricity RA600-00103109, UDI UDI not required, System ID 949759RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 103594-1-Centricity RA600-00108922, UDI UDI not required, System ID NOIRA010; Model/Catalog/Code # 2033901-001, Installed Product ID 103468-2-Centricity RA600-00102825, UDI UDI not required, System ID 925296RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 102186-5-Centricity RA600-00099569, UDI UDI not required, System ID 530876RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-52-Centricity RA600-00098941, UDI UDI not required, System ID 502555RWSW69; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-50-Centricity RA600-00098940, UDI UDI not required, System ID 502555RWSW68; Model/Catalog/Code # 2033901-001, Installed Product ID 11032-2-Centricity RA600-00102406, UDI UDI not required, System ID 909788RA600CL1; Model/Catalog/Code # 2033901-001, Installed Product ID 103446-1-Centricity RA600-00101508, UDI UDI Not Required, System ID 707963RA6SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 102898-1-Centricity RA600-00105988, UDI UDI not required, System ID 831757RW3; Model/Catalog/Code # 2033901-001, Installed Product ID 10117-1-Centricity RA600-00105908, UDI UDI Not Required, System ID 818676DHC1SW; Model/Catalog/Code # 2033901-001, Installed Product ID 10617-1-Centricity RA600-00109046, UDI UDI not required, System ID PSLDIGSW; Model/Catalog/Code # 2033901-001, Installed Product ID 4246-1-Centricity RA600-00107014, UDI UDI Not Required, System ID 303825RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10482-1-Centricity RA600-00103221, UDI UDI not required, System ID 970247RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 8142-4-Centricity RA600-00103242, UDI UDI not required, System ID 970477RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10288-3-Centricity RA600-00105703, UDI UDI not required, System ID 816348RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10508-1-Centricity RA600-00103222, UDI UDI not required, System ID 970249RA6SW; Model/Catalog/Code # 2033901-001, Installed Product ID 103814-1-Centricity RA600-00103249, UDI UDI Not Required, System ID 970728RA600SW; Model/Catalog/Code # 2033901-001, Installed Product ID 9900-1-Centricity RA600-00106910, UDI UDI not required, System ID 303451RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 101194-2-Centricity RA600-00103079, UDI UDI not required, System ID 941798DHC1SW; Model/Catalog/Code # 2033901-001, Installed Product ID 10298-1-Centricity RA600-00105471, UDI UDI not required, System ID 813571RA6CSW; Model/Catalog/Code # 2033901-001, Installed Product ID 11209-1-Centricity RA600-00104309, UDI UDI not required, System ID WFDVOHCCD001SW; Model/Catalog/Code # 2033901-001, Installed Product ID 10218-2-Centricity RA600-00108496, UDI UDI not required, System ID FWMCCSRA211; Model/Catalog/Code # 2033901-001, Installed Product ID 10569-1-Centricity RA600-00098014, UDI UDI not required, System ID 407518DHCOICSW; Model/Catalog/Code # 2033901-001, Installed Product ID 103332-2-Centricity RA600-00095933, UDI UDI not required, System ID 17219II7; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-8-Centricity RA600-00098877, UDI UDI not required, System ID 502555RW64; Model/Catalog/Code # 2033901-001, Installed Product ID 103528-2-Centricity RA600-00106286, UDI UDI not required, System ID 850678RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 103605-1-Centricity RA600-00107991, UDI UDI not required, System ID 352401RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 9859-79-Centricity RA600-01270494, UDI UDI Not Required, System ID 727834RA6SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10264-1-Centricity RA600-00106320, UDI UDI not required, System ID 850769RA6001; Model/Catalog/Code # 2033901-001, Installed Product ID 103540-1-Centricity RA600-00104913, UDI UDI not required, System ID 772335RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10475-1-Centricity RA600-00097980, UDI UDI not required, System ID 407321RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 103579-1-Centricity RA600-00105481, UDI UDI not required, System ID 813634RA6SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10729-1-Centricity RA600-00102446, UDI UDI Not Required, System ID 912466RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10147-2-Centricity RA600-00096866, UDI UDI Not Required, System ID 229276RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 9847-2-Centricity RA600-00108219, UDI UDI not required, System ID 404501RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 11047-1-Centricity RA600-00108419, UDI UDI not required, System ID EJCHDHCSW; Model/Catalog/Code # 2033901-001, Installed Product ID 103778-1-Centricity RA600-00098702, UDI UDI not required, System ID 478745RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 2317-3-Centricity RA600-00098696, UDI UDI Not Required, System ID 478633RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10106-1-Centricity RA600-00103772, UDI UDI not required, System ID CHSYDHC1SW; Model/Catalog/Code # 2033901-001, Installed Product ID 102608-2-Centricity RA600-00097959, UDI UDI not required, System ID 406238RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 4148-1-Centricity RA600-00107760, UDI UDI not required, System ID 319369RA600B; Model/Catalog/Code # 2033901-001, Installed Product ID 105197-2-Centricity RA600-00107753, UDI UDI not required, System ID 319272RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10788-2-Centricity RA600-00096200, UDI UDI not required, System ID 208743RW1SW; Model/Catalog/Code # 2033901-001, Installed Product ID 10804-1-Centricity RA600-00104286, UDI UDI not required, System ID W8010268; Model/Catalog/Code # 2033901-001, Installed Product ID 103989-1-Centricity RA600-00104955, UDI UDI not required, System ID 773525RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 101454-1-Centricity RA600-00096964, UDI UDI Not Required, System ID 256315RA600SW; Model/Catalog/Code # 2033901-001, Installed Product ID 10135-2-Centricity RA600-00100898, UDI UDI not required, System ID 630572RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 4539-1-Centricity RA600-00105627, UDI UDI not required, System ID 815539RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 10251-2-Centricity RA600-00100784, UDI UDI not required, System ID 618241RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 103232-1-Centricity RA600-00157042, UDI UDI not required, System ID 630788RA6SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 9914-7-Centricity RA600-01370535, UDI UDI Not Required, System ID SH1801370535; Model/Catalog/Code # 2033901-001, Installed Product ID 9788-2-Centricity RA600-00105648, UDI UDI not required, System ID 815673RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 103543-2-Centricity RA600-00096981, UDI UDI Not Required, System ID 260435RA6SW2; Model/Catalog/Code # 2033901-001, Installed Product ID 103588-1-Centricity RA600-00108476, UDI UDI not required, System ID FRNKBRN01SW; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098870, UDI UDI not required, System ID 502555RA600SW1; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098871, UDI UDI not required, System ID 502555RADSW1; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098872, UDI UDI not required, System ID 502555RADSW2; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098874, UDI UDI not required, System ID 502555RADSW4; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098875, UDI UDI not required, System ID 502555RADSW5; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098876, UDI UDI not required, System ID 502555RADSW6; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098879, UDI UDI not required, System ID 502555RWSW10; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098881, UDI UDI not required, System ID 502555RWSW12; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098882, UDI UDI not required, System ID 502555RWSW13; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098884, UDI UDI not required, System ID 502555RWSW15; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098885, UDI UDI not required, System ID 502555RWSW16; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098886, UDI UDI not required, System ID 502555RWSW17; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098887, UDI UDI not required, System ID 502555RWSW18; Model/Catalog/Code # 2033901-001, Installed Product ID 3456-59-Centricity RA600-00098888, UDI UDI not required, System ID 502555RWSW19…
Recall started
Feb. 19, 2025
Device type
System, Image Processing, Radiological
Root cause (FDA)
Software design
What the company told customers
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification. Please ensure you have implemented the actions below: 1: Ensure your hospital network is secure and 2: Outside of the hospital network implement additional safeguards such as a VPN. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.85480@gehealthcare.com." "If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
Recall number
Z-1485-2025

GE Healthcare Centricity Cardiology CA1000 (CA1000)…

Product
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
Quantity
633 units
Codes and lots
Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI UDI Not Required, System ID 520855CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103987-1-Centricity CA1000-00102841, UDI UDI Not Required, System ID 928537CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9990-1-Centricity CA1000-00101135, UDI UDI not required, System ID 661327CWS01; Model/Catalog/Code # 2038437-001, Installed Product ID 10318-1-Centricity CA1000-00105877, UDI UDI not required, System ID 818397CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10994-1-Centricity CA1000-00102387, UDI UDI Not required, System ID 909464CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102131-1-Centricity CA1000-00105886, UDI UDI not required, System ID 818409CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4161-1-Centricity CA1000-00105894, UDI UDI Not Required, System ID 818502CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103743-1-Centricity CA1000-00099665, UDI UDI Not Required, System ID 559582CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4408-2-Centricity CA1000-00101725, UDI UDI not required, System ID 714843CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 4532-4-Centricity CA1000-00107356, UDI UDI Not Required, System ID 310673CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4009-2-Centricity CA1000-00100791, UDI UDI not required, System ID 619260CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1354-8-Centricity CA1000-00102389, UDI UDI not required, System ID 909558CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9927-2-Centricity CA1000-00099762, UDI UDI not required, System ID 562491CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11299-9-Centricity CA1000-00109567, UDI UDI Not Required, System ID SVMCA6; Model/Catalog/Code # 2038437-001, Installed Product ID 4446-2-Centricity CA1000-00107805, UDI (01)00840682125260(10)20P14H2038437016, System ID 323726CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103447-1-Centricity CA1000-22271916, UDI (01)00840682125260(10)20P14J2038437016, System ID CALIFORNIA22271916; Model/Catalog/Code # 2038437-001, Installed Product ID 100256-3-Centricity CA1000-00101156, UDI (01)00840682125260(10)20P14J2038437016, System ID 661948CA1RSW; Model/Catalog/Code # 2038437-001, Installed Product ID 11169-1-Centricity CA1000-00102586, UDI UDI not required, System ID 916225CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1223-17-Centricity CA1000-00106365, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 858554CA1SW14; Model/Catalog/Code # 2038437-001, Installed Product ID 1845-2-Centricity CA1000-00100829, UDI UDI not required, System ID 619691CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 2195-12-Centricity CA1000-16385905, UDI UDI Not Required, System ID UCLAMC16385905; Model/Catalog/Code # 2038437-001, Installed Product ID 9985-1-Centricity CA1000-00106974, UDI UDI not required, System ID 303695CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103533-5-Centricity CA1000-02299486, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID BOULDERCO02299486; Model/Catalog/Code # 2038437-001, Installed Product ID 10617-1-Centricity CA1000-00107034, UDI UDI not required, System ID 303839CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100385-1-Centricity CA1000-00106873, UDI UDI not required, System ID 303320CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10482-1-Centricity CA1000-00103250, UDI UDI not required, System ID 970764CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10841-1-Centricity CA1000-00106998, UDI UDI not required, System ID 303788CVIT5; Model/Catalog/Code # 2038437-001, Installed Product ID 9900-1-Centricity CA1000-00106902, UDI UDI not required, System ID 303451CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 2386-2-Centricity CA1000-00116051, UDI UDI not required, System ID 203276CA1000RV1; Model/Catalog/Code # 2038437-001, Installed Product ID 101581-1-Centricity CA1000-00095981, UDI UDI not required, System ID 202745CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4698-3-Centricity CA1000-00108747, UDI UDI not required, System ID MCTHCA10001; Model/Catalog/Code # 2038437-001, Installed Product ID 101194-2-Centricity CA1000-00103078, UDI UDI not required, System ID 941792HCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10298-1-Centricity CA1000-00105482, UDI UDI not required, System ID 813681CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10298-1-Centricity CA1000-00105491, UDI UDI not required, System ID 813681CA1SW19; Model/Catalog/Code # 2038437-001, Installed Product ID 11209-1-Centricity CA1000-00095905, UDI UDI not required, System ID 0004053422A; Model/Catalog/Code # 2038437-001, Installed Product ID 10218-4-Centricity CA1000-00108483, UDI UDI not required, System ID FWBCA1005; Model/Catalog/Code # 2038437-001, Installed Product ID 10218-2-Centricity CA1000-00095912, UDI UDI not required, System ID FWBCA14; Model/Catalog/Code # 2038437-001, Installed Product ID 103638-1-Centricity CA1000-00107955, UDI UDI not required, System ID 352331CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10849-3-Centricity CA1000-00107230, UDI UDI Not Required, System ID 305364CA2100; Model/Catalog/Code # 2038437-001, Installed Product ID 103203-1-Centricity CA1000-22144957, UDI (01)00840682125260(10)20P14J2038437016, System ID BIHT22144957; Model/Catalog/Code # 2038437-001, Installed Product ID 10458-5-Centricity CA1000-00102189, UDI UDI not required, System ID 904399HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11208-2-Centricity CA1000-00103172, UDI UDI not required, System ID 954974CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 101427-1-Centricity CA1000-00104669, UDI UDI not required, System ID 727848HCA1SW7; Model/Catalog/Code # 2038437-001, Installed Product ID 10264-1-Centricity CA1000-00095914, UDI UDI not required, System ID 850769HCA1SW11; Model/Catalog/Code # 2038437-001, Installed Product ID 101180-1-Centricity CA1000-00104672, UDI UDI not required, System ID 727863CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103577-2-Centricity CA1000-00104941, UDI UDI not required, System ID 772581CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 104179-1-Centricity CA1000-00104625, UDI UDI Not required, System ID 727521CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103788-1-Centricity CA1000-00104637, UDI UDI not required, System ID 727521OPCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11639-1-Centricity CA1000-00104600, UDI UDI not required, System ID 727384CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10475-1-Centricity CA1000-00097981, UDI UDI not required, System ID 407321SWCA1; Model/Catalog/Code # 2038437-001, Installed Product ID 11041-1-Centricity CA1000-00103047, UDI UDI Not Required, System ID 941342CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11743-1-Centricity CA1000-00095913, UDI (01)00840682125260(10)20P14H2038437016, System ID 0004275549A; Model/Catalog/Code # 2038437-001, Installed Product ID 11743-1-Centricity CA1000-01973685, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID 850325HCA1SW5; Model/Catalog/Code # 2038437-001, Installed Product ID 13367-1-Centricity CA1000-02041150, UDI (01)00840682125260(10)2.0SPA142038437016B, System ID HCAE02041150; Model/Catalog/Code # 2038437-001, Installed Product ID 100620-13-Centricity CA1000-00163680, UDI UDI not required, System ID 813885HCA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1657-7-Centricity CA1000-00105550, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID 813971CA10003; Model/Catalog/Code # 2038437-001, Installed Product ID 10292-2-Centricity CA1000-00104678, UDI UDI Not Required, System ID 727942CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100115-1-Centricity CA1000-00101433, UDI UDI Not Required, System ID 706651HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3901-2-Centricity CA1000-00101421, UDI UDI not required, System ID 706596CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10147-2-Centricity CA1000-22155331, UDI (01)00840682125260(10)20P14J2038437016, System ID CRH522155331; Model/Catalog/Code # 2038437-001, Installed Product ID 9847-2-Centricity CA1000-00108204, UDI UDI not required, System ID 404501CA1SW1A; Model/Catalog/Code # 2038437-001, Installed Product ID 10209-1-Centricity CA1000-00098680, UDI UDI Not Required, System ID 478274CA1SW100; Model/Catalog/Code # 2038437-001, Installed Product ID 11047-6-Centricity CA1000-00101185, UDI UDI not required, System ID 678957CA1; Model/Catalog/Code # 2038437-001, Installed Product ID 11047-6-Centricity CA1000-00101186, UDI UDI not required, System ID 678957CA2; Model/Catalog/Code # 2038437-001, Installed Product ID 3929-2-Centricity CA1000-00105388, UDI UDI not required, System ID 808485CA1SW2; Model/Catalog/Code # 2038437-001, Installed Product ID 1458-6-Centricity CA1000-00107439, UDI UDI Not Required, System ID 312RUSH1CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 1566-4-Centricity CA1000-00102050, UDI UDI not required, System ID 877453CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 1566-4-Centricity CA1000-00102051, UDI UDI not required, System ID 877453CA1SW2; Model/Catalog/Code # 2038437-001, Installed Product ID 101349-2-Centricity CA1000-00109702, UDI (01)00840682125260(10)2.0SP14C2038437016C, System ID UICCA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 101349-2-Centricity CA1000-22176245, UDI (01)00840682125260(10)20P14J2038437016, System ID UIMC22176245; Model/Catalog/Code # 2038437-001, Installed Product ID 101454-1-Centricity CA1000-00101519, UDI UDI Not Required, System ID 708202CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10691-2-Centricity CA1000-00096590, UDI UDI Not required, System ID 217258CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 11367-1-Centricity CA1000-00101569, UDI UDI not required, System ID 708681CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10251-3-Centricity CA1000-00100783, UDI UDI not required, System ID 618241CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 100086-1-Centricity CA1000-00107335, UDI UDI not required, System ID 309CA1000SW4; Model/Catalog/Code # 2038437-001, Installed Product ID 1250-1-Centricity CA1000-00101545, UDI UDI Not Required, System ID 708361CA1000SW; Model/Catalog/Code # 2038437-001, Installed Product ID 1237-1-Centricity CA1000-00103189, UDI UDI Not Required, System ID 956544CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3832-1-Centricity CA1000-00105463, UDI UDI not required, System ID 812858CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 8637-1-Centricity CA1000-00107663, UDI UDI not required, System ID 317621CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 3864-3-Centricity CA1000-00105445, UDI (01)00840682125260(10)20P14J2038437016, System ID 812482CA1SW; Model/Catalog/Code # 2038437-001, Installed Product ID 102796-1-Centricity CA1000-00104871, UDI UDI not required, System ID 765671CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10943-1-Centricity CA1000-00107645, UDI (01)00840682125260(10)20P14F2038437016, System ID 316962HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103613-1-Centricity CA1000-00107629, UDI UDI not required, System ID 316858HCACA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103897-1-Centricity CA1000-00097067, UDI…
Recall started
Feb. 19, 2025
Device type
System, Image Processing, Radiological
Root cause (FDA)
Software design
What the company told customers
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification. Please ensure you have implemented the actions below: 1: Ensure your hospital network is secure and 2: Outside of the hospital network implement additional safeguards such as a VPN. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.85480@gehealthcare.com." "If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
Recall number
Z-1486-2025

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer…

Product
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
Quantity
4 units
Codes and lots
Model/catalog/code # 2049587-015, Installed Product ID 100707-1-Centricity Universal Viewer-00558649, UDI UDI Not Required, System ID PACS-IW-126; Model/catalog/code # 2066908-086, Installed Product ID 9842-4-Centricity Universal Viewer-19386293, UDI UDI Not Required, System ID GA001PACTRL01; Model/catalog/code # 2066908-136, Installed Product ID ZA2533-Centricity Universal Viewer-00116577, UDI UDI Not Required, System ID ZA2533PAC1; Model/catalog/code # 2104867-045, Installed Product ID X9003062 - HC3062-Centricity Universal Viewer-01462397, UDI (01)00840682103800(10)6.0SP50412094097001D, System ID HC3062UV01.
Recall started
Feb. 19, 2025
Device type
System, Image Processing, Radiological
Root cause (FDA)
Software design
What the company told customers
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification. Please ensure you have implemented the actions below: 1: Ensure your hospital network is secure and 2: Outside of the hospital network implement additional safeguards such as a VPN. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.85480@gehealthcare.com." "If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
Recall number
Z-1487-2025

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-1483-2025, Z-1484-2025, Z-1485-2025, Z-1486-2025, Z-1487-2025. The agency record governs; check it and the company before acting.

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