PlainRecordsFDA · Medical device recall
Centricity PACS-IW with Universal Viewer… and 2 more products
- Date
- May 10, 2023
- 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
- GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
- Distribution pattern
- Worldwide Distribution
3 products in this recall
Centricity PACS-IW with Universal Viewer…
- Product
- Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; Radiological Image Processing System
- Quantity
- 17 units
- Codes and lots
- No UDI/DI for these products: a) 2066908-061, Product ID Numbers: HC3062-Centricity Universal Viewer-01462397; b) 2066908-077, Product ID Numbers: YP3150-Centricity Universal Viewer-01639018; c) 2066908-086, Product ID Numbers: 100707-1-Centricity Universal Viewer-00558649, 9842-4-Centricity Universal Viewer-19386293; d) 2066908-111, Product ID Numbers: 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785; e) 2066908-123, Product ID Numbers: 4705-1-Centricity Universal Viewer-02398923; f) 2066908-136, Product ID Numbers: 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, ZA2533-Centricity Universal Viewer-00116577, 280801-Centricity Universal Viewer-19737221; g) 2066908-150, Product ID Numbers: 100759-1-Centricity Universal Viewer-02360986, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 100512-1-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, RU9761-UW PACS-IW UP TO 10K-02336112
- Recall started
- March 28, 2023
- Device type
- System, Image Processing, Radiological
- Root cause (FDA)
- Other
- What the company told customers
- GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction.
- Recall number
- Z-1500-2023
Centricity Universal Viewer…
- Product
- Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System
- Quantity
- 329 units
- Codes and lots
- a) 2088026-003, No UDI/DI, Product ID numbers: 233637-Centricity Universal Viewer-15773152; b) 2088026-026, No UDI/DI, Product ID numbers: 4446-2-Centricity Universal Viewer-00558643, 4491-1-Centricity Universal Viewer-00558690, 100256-3-Centricity Universal Viewer-00558700, 100256-3-Centricity Universal Viewer-01810788, 102143-1-Centricity Universal Viewer-00558685, 101044-1-Centricity Universal Viewer-00558694, 13356-2-Centricity Universal Viewer-00558681, 102335-1-Centricity Universal Viewer-00558675, 13228-1-Centricity Universal Viewer-00558678, 101274-1-Centricity Universal Viewer-00558679, 101274-1-Centricity Universal Viewer-20279342, 13125-1-Centricity Universal Viewer-02268546, 102359-1-Centricity Universal Viewer-00558696, 4578-1-Centricity Universal Viewer-00558340, A54120-Centricity Universal Viewer-00040449, KW0000-Centricity Universal Viewer-01416913, BON01-Centricity Universal Viewer-00044131, PL3277-Centricity Universal Viewer-00038831; c) 2088026-032, No UDI/DI, Product ID numbers: 1027-1-Centricity Universal Viewer-00558706, 1027-1-Centricity Universal Viewer-20759776, 124774-Centricity Universal Viewer-00000208; d) 2088026-043, No UDI/DI, Product ID numbers: 4441-1-Centricity Universal Viewer-00558677, PL3349-Centricity Universal Viewer-00038811, RU3866-Centricity Universal Viewer-01445731, RU8945-Centricity Universal Viewer-01445740, RU2580-Centricity Universal Viewer-01445743, RU7175-Centricity Universal Viewer-01445748, RU1646-Centricity Universal Viewer-01445763, RU3453-Centricity Universal Viewer-01273249, TBD-Centricity Universal Viewer-01273292; e) 2088026-044, No UDI/DI, Product ID numbers: 237870-Centricity Universal Viewer-01444278; f) 2088026-115, No UDI/DI, Product ID numbers: 4413-2-Centricity Universal Viewer-01300927, 4413-2-Centricity Universal Viewer-01300929, 100837-1-Centricity Universal Viewer-00558435, 100837-1-Centricity Universal Viewer-17594527, 13240-2-Centricity Universal Viewer-00558103, 11042-1-Centricity Universal Viewer-02285888, 11042-1-Centricity Universal Viewer-19603374; g) 2088026-132, No UDI/DI, Product ID numbers: A91901-Centricity Universal Viewer-00044549, CC4105-Centricity Universal Viewer-01282278, HC4105-Centricity Universal Viewer-00001393, 651948-Centricity Universal Viewer-01813739; h) 2088026-306, UDI/DI840682103800, Product ID numbers: 11438-1-Centricity Universal Viewer-00558464, 101280-1-Centricity Universal Viewer-19630915, ZA2541-Centricity Universal Viewer-01985829, ZA2472-Centricity Universal Viewer-00116565; i) 2088026-308, UDI/DI 840682103800, Product ID numbers: 4267-5-Centricity Universal Viewer-19618406, 100763-1-Centricity Universal Viewer-00558366, 101280-1-Centricity Universal Viewer-19630914, 101280-1-Centricity Universal Viewer-19630916, 101280-1-Centricity Universal Viewer-20553950, 4451-1-Centricity Universal Viewer-00558107, 101170-1-Centricity Universal Viewer-00558305, 4483-1-Centricity Universal Viewer-00558457, 4483-1-Centricity Universal Viewer-20583582, PL2975-Centricity Universal Viewer-00162605, 318055-Centricity Universal Viewer-01457316, 4267-5-Centricity Universal Viewer-20884363, 4267-5-Centricity Universal Viewer-20884364, 4267-5-Centricity Universal Viewer-20884365; j) 2088026-406, UDI/DI 840682103800, Product ID numbers: 4552-1-Centricity Universal Viewer-01294074, 100029-1-Centricity Universal Viewer-02256808, 100717-1-Centricity Universal Viewer-01293807, 100717-1-Centricity Universal Viewer-01293808, 13345-1-Centricity Universal Viewer-00602707, 8746-1-Centricity Universal Viewer-01448329, 4683-1-Centricity Universal Viewer-00558456, 4487-1-Centricity Universal Viewer-01291589, 4487-1-Centricity Universal Viewer-02097167, 571064-Centricity Universal Viewer-01293639, 786787-Centricity Universal Viewer-01283171; k) 2088026-506, UDI/DI 840682103800, Product ID numbers: 9094-1-Centricity Universal Viewer-01766830, 100770-1-Centricity Universal Viewer-01804127, 313741-Centricity Universal Viewer-02097256, 268034-Centricity Universal Viewer-18862276, RU1107-Centricity Universal Viewer-01813331, RU5388-Centricity Universal Viewer-01719556, 16218680-Centricity Universal Viewer-02266272, ZA2267-Centricity Universal Viewer-02001877; l) 2088026-613, UDI/DI 840682103800, Product ID numbers: 1011-1-Centricity Universal Viewer-00558109, 1011-1-Centricity Universal Viewer-02097166, 1011-1-Centricity Universal Viewer-02097165, 100159-1-Centricity Universal Viewer-00558324, 101598-1-Centricity Universal Viewer-00667138, 104491-1-Centricity Universal Viewer-01288014; m) 2088026-713, No UDI/DI, Product ID numbers: 2403-7-Centricity Universal Viewer-00558347, RU1107-Centricity Universal Viewer-01273207, MPX352-Centricity Universal Viewer-19629107, DP7603-Centricity Universal Viewer-20093544, FP5028-Centricity Universal Viewer-00110911; UDI/DI 840682103800, Product ID numbers: 4362-1-Centricity Universal Viewer-01299095, 4362-1-Centricity Universal Viewer-19732280, HC0399-Centricity Universal Viewer-01282972, 509585-Centricity Universal Viewer-01826272, 81111-Centricity Universal Viewer-01286673, AMS39-Centricity Universal Viewer-00545606, 85021-Centricity Universal Viewer-01426096; n) 2088026-714, No UDI/DI, Product ID numbers: 4379-1-Centricity Universal Viewer-02184891; UDI/DI 840682103800, Product ID numbers: 101690-1-Centricity Universal Viewer-20091140, 531344-Centricity Universal Viewer-00000707; o) 2088026-723, UDI/DI 840682103800, Product ID numbers: 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 4415-1-Centricity Universal Viewer-01973510, 4318-1-Centricity Universal Viewer-00558703, 4318-1-Centricity Universal Viewer-20080694, 9768-1-Centricity Universal Viewer-00558661, 9768-1-Centricity Universal Viewer-01972254, 4353-2-Centricity Universal Viewer-01589220, 4698-1-Centricity Universal Viewer-00558313, 101725-2-Centricity Universal Viewer-00558642, 4687-1-Centricity Universal Viewer-00558334, 100366-1-Centricity Universal Viewer-00558522, 100366-1-Centricity Universal Viewer-14777071, 100718-2-Centricity Universal Viewer-02350739, 100718-1-Centricity Universal Viewer-02373799, 12968-1-Centricity Universal Viewer-02277843, 12968-1-Centricity Universal Viewer-02278145, 9852-2-Centricity Universal Viewer-00558644, 9852-2-Centricity Universal Viewer-02267839, 9852-2-Centricity Universal Viewer-01271417, 4391-1-Centricity Universal Viewer-02205222, 4391-3-Centricity Universal Viewer-01459013, 4698-11-Centricity Universal Viewer-19667347, 4698-11-Centricity Universal Viewer-15961473, 4382-1-Centricity Universal Viewer-02268547, 4433-1-Centricity Universal Viewer-00558704, 4433-1-Centricity Universal Viewer-17737529, 4669-1-Centricity Universal Viewer-00558691, 4669-1-Centricity Universal Viewer-14768587, 12961-1-Centricity Universal Viewer-00558236, 4306-3-Centricity Universal Viewer-00558573, 4306-1-Centricity Universal Viewer-02263351, 4306-3-Centricity Universal Viewer-02345023, 4306-3-Centricity Universal Viewer-02288781, 100092-1-Centricity Universal Viewer-15531177, 100092-1-Centricity Universal Viewer-14767331, 100092-1-Centricity Universal Viewer-00558648, 100092-1-Centricity Universal Viewer-00558697, 1057-1-Centricity Universal Viewer-02180910, 1057-1-Centricity Universal Viewer-00558402, 1057-1-Centricity Universal Viewer-14961014, 101690-1-Centricity Universal Viewer-00558680, 9796-1-Centricity Universal Viewer-00558571, 9752-1-Centricity Universal Viewer-02393053, 9752-1-Centricity Universal Viewer-00558454, 100468-1-Centricity Universal Viewer-02287985, 100468-1-Centricity Universal Viewer-02288300, 101310-1-Centricity Universal Viewer-02039946, AP6264-Centricity Universal Viewer-00000180, 313741-Centricity Universal Viewer-01422997, 313741-Centricity Universal Viewer-15591262, 000282202-Centricity Universal Viewer-02291736, HBON01-Centricity Universal Viewer-00260801, 691749-Centricity Universal Viewer-01539092, 509940-Centricity Universal Viewer-01813036, HC0529-Centricity Universal Viewer-01364776, HC0245-Centricity Universal Viewer-00059319, 600791-Centricity Universal Viewer-02099049, HC1414-Centricity Universal Viewer-01814335, PC0023-Centricity Universal Viewer-01282279, CC0154-Centricity Universal Viewer-01813738, 601860-Centricity Universal Viewer-01373156, HC0565-Centricity Universal Viewer-00545595, HC4357-Centricity Universal Viewer-02090320, PL1190-Centricity Universal Viewer-21245580, RU8414-Centricity Universal Viewer-01445730, RU7519-Centricity Universal Viewer-01816694, RU4255-Centricity Universal Viewer-02331160, RU0003-Centricity Universal Viewer-02335931, RU9059-Centricity Universal Viewer-01445746, RU9327-Centricity Universal Viewer-02337466, RU1011-Centricity Universal Viewer-02330918, RU1112-Centricity Universal Viewer-01453917, RU1112-Centricity Universal Viewer-01977813, RU1112-Centricity Universal Viewer-01980259, RU1516-Centricity Universal Viewer-02331146, RU1717-Centricity Universal Viewer-01476628, RU0472-Centricity Universal Viewer-02092677, RU3052-Centricity Universal Viewer-02330856, 600101-Centricity Universal Viewer-01273190, RU1544-Centricity Universal Viewer-02330871, RU2526-Centricity Universal Viewer-02331246, RU0994-Centricity Universal Viewer-02331254, RU3794-Centricity Universal Viewer-19673911, RU9226-Centricity Universal Viewer-19673912, RU8356-Centricity Universal Viewer-01445768, 600105-Centricity Universal Viewer-02331152, RU9697-Centricity Universal Viewer-19673913, 2422939-Centricity Universal Viewer-01509505, RU3998-Centricity Universal Viewer-01553790, 482896-Centricity Universal Viewer-00545574, 941804-Centricity Universal Viewer-02287043, 4305-7-Centricity Universal Viewer-16204605, 4305-7-Centricity Universal Viewer-16204606, 4305-7-Centricity Universal Viewer-16204607, 4305-7-Centricity Universal Viewer-16204608, 4305-7-Centricity Universal Viewer-16204609, 4305-7-Centricity Universal Viewer-16204612, 4305-7-Centricity Universal Viewer-16204613; p) 2099714-001, UDI/DI 840682103800, Product ID numbers: 4449-1-Centricity Universal Viewer-00558276, 4449-1-Centricity Universal Viewer-20689478; q) 2100169-001, UDI/DI 840682103800, Product ID numbers: 102123-1-Centricity Universal Viewer-00558570, 102123-1-Centricity Universal Viewer-02157634, 4415-1-Centricity Universal Viewer-00558359, 104287-2-Centricity Universal Viewer-00555505, 4583-1-Centricity Universal Viewer-01367198, 2337-5-Centricity Universal Viewer-01810490, 2337-5-Centricity Universal Viewer-19670358, 12902-1-Centricity Universal Viewer-00602638, 4585-3-Centricity Universal Viewer-01448365, 4585-3-Centricity Universal Viewer-20502096, 1530-1-Centricity Universal Viewer-00558491, 1530-12-Centricity Universal Viewer-01301357, 13295-1-Centricity Universal Viewer-01292684, 13295-1-Centricity Universal Viewer-19609993, 13295-1-Centricity Universal Viewer-19611189, 100971-1-Centricity Universal Viewer-00558469, 4637-1-Centricity Universal Viewer-00558372, 4637-1-Centricity Universal Viewer-02176556, 8746-1-Centricity Universal Viewer-00558308, 2403-7-Centricity Universal Viewer-01973509, 4347-1-Centricity Universal Viewer-00558520; r) 2100491-006, UDI/DI 840682103800, Product ID numbers: 13162-8-Centricity Universal Viewer-01452133, 13162-8-Centricity Universal Viewer-14776447, 13162-8-Centricity Universal Viewer-14776449, 3245-1-Centricity Universal Viewer-01451973, 100864-1-Centricity Universal Viewer-00558400, 100769-1-Centricity Universal Viewer-01298556, 100769-1-Centricity Universal Viewer-02395799, 12966-1-Centricity Universal Viewer-01283020, 12966-1-Centricity Universal Viewer-20025013, RU8366-Centricity Universal Viewer-18045776, RU9595-Centricity Universal Viewer-01812133, RU9546-Centricity Universal Viewer-01812747; s) 2102675-010, UDI/DI 840682103800, Product ID numbers: PC1695-Centricity Universal Viewer-01447701, PC1961-Centricity Universal Viewer-00001720, SA1339-Centricity Universal Viewer-00116444; t) 2102676-001, UDI/DI 840682103800, Product ID numbers: 100104-1-Centricity Universal…
- Recall started
- March 28, 2023
- Device type
- System, Image Processing, Radiological
- Root cause (FDA)
- Other
- What the company told customers
- GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction.
- Recall number
- Z-1501-2023
Centricity PACS-IW…
- Product
- Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e) 2049587-012, f) 2049587-015, g) 2052829-001, h) Not applicable; Radiological Image Processing System
- Quantity
- 153 units
- Codes and lots
- a) 2041037-001, No UDI/DI, Product ID Numbers: 4443-1-Centricity PACS-IW-00558167; b) 2042988-001, No UDI/DI, Product ID Numbers: 707509-Centricity PACS-IW-01452391, 613493-Centricity PACS-IW-02292544, SiteID-Centricity PACS-IW-01572187; c) 2049587-009, No UDI/DI, Product ID Numbers: 1402-7-Centricity PACS-IW-18957305, 1402-7-Centricity PACS-IW-19265438, 1402-7-Centricity PACS-IW-18166109, 1402-7-Centricity PACS-IW-18166110, 1402-2-Centricity PACS-IW-18984905, 1402-2-Centricity PACS-IW-18985934, 1402-2-Centricity PACS-IW-19031647, 1402-1-Centricity PACS-IW-17192703, 1402-1-Centricity PACS-IW-17192704, 1402-1-Centricity PACS-IW-00558291, 4276-1-Centricity PACS-IW-00558274, 12974-1-Centricity PACS-IW-00558300, 4482-1-Centricity PACS-IW-00558281, BA4080-Centricity PACS-IW-00038769, 320090-Centricity PACS-IW-01444604, HOLY-FAMILY-THODU-Centricity PACS-IW-01821493, RU3382-Centricity PACS-IW-01273247, RU3680-Centricity PACS-IW-01273260, RU3380-Centricity PACS-IW-01273246; d) 2049587-011, No UDI/DI, Product ID Numbers: 12830-1-Centricity PACS-IW-00558312, 4352-1-Centricity PACS-IW-00558316, PL1825-Centricity PACS-IW-00038819, 14335625-Centricity PACS-IW-20614918; e) 2049587-012, No UDI/DI, Product ID Numbers: 100858-1-Centricity PACS-IW-00558426, 4109-1-Centricity PACS-IW-00558389, 4294-1-Centricity PACS-IW-00558379, 13039-1-Centricity PACS-IW-00558385, 101742-1-Centricity PACS-IW-00558470, 9791-1-Centricity PACS-IW-00558418, 11764-1-Centricity PACS-IW-00558388, 101689-1-Centricity PACS-IW-00558326, 4744-1-Centricity PACS-IW-00558373, 4374-1-Centricity PACS-IW-00558422, 4277-1-Centricity PACS-IW-00558474, 101216-1-Centricity PACS-IW-00558356, 101240-1-Centricity PACS-IW-00558425, 4361-1-Centricity PACS-IW-00558343, 12949-1-Centricity PACS-IW-00558442, 4393-1-Centricity PACS-IW-00558328, 100645-1-Centricity PACS-IW-14764451, 4573-1-Centricity PACS-IW-00558420, 4506-1-Centricity PACS-IW-00558345, AZ4030-Centricity PACS-IW-02336621, 324462-Centricity PACS-IW-01431554, 246838-Centricity PACS-IW-01421153, 280801-Centricity PACS-IW-01431490, 307319-Centricity PACS-IW-01444609, StThomas-Centricity PACS-IW-01819447, WOCKHARDT-Centricity PACS-IW-01819449, SIMS-Centricity PACS-IW-01819453, MARTHANDAM-Centricity PACS-IW-01819446, CONTINENTAL-Centricity PACS-IW-01819443, KW1112-Centricity PACS-IW-00168151, BEVERLY-Centricity PACS-IW-01288659, MAHKOTA-Centricity PACS-IW-01286179, UMUM-Centricity PACS-IW-01288666, RU2580-Centricity PACS-IW-01273240, ONCOLOGY-Centricity PACS-IW-01288658; f) 2049587-015, No UDI/DI, Product ID Numbers: 4345-1-Centricity PACS-IW-00558548, 101792-1-Centricity PACS-IW-00558370, 4378-1-Centricity PACS-IW-00558498, 100663-1-Centricity PACS-IW-00558514, 100702-1-Centricity PACS-IW-00558539, 101625-1-Centricity PACS-IW-00558531, 4593-1-Centricity PACS-IW-00558488, 100009-1-Centricity PACS-IW-00558560, 100838-1-Centricity PACS-IW-00558532, 13102-1-Centricity PACS-IW-00558512, 4694-1-Centricity PACS-IW-00558556, 101883-1-Centricity PACS-IW-00558487, 4358-1-Centricity PACS-IW-00558564, 13095-1-Centricity PACS-IW-00558534, 4326-4-Centricity PACS-IW-00558105, 4301-1-Centricity PACS-IW-00558525, 2387-1-Centricity PACS-IW-00558489, 100802-1-Centricity PACS-IW-00558540, 101193-1-Centricity PACS-IW-00558551, 4661-1-Centricity PACS-IW-00558528, 3943-1-Centricity PACS-IW-00558501, 4383-1-Centricity PACS-IW-00558533, 13233-3-Centricity PACS-IW-00558554, 4389-1-Centricity PACS-IW-00558563, 302144-Centricity PACS-IW-01421157, 213537-Centricity PACS-IW-01431510, 319674-Centricity PACS-IW-01431535, RMUE01-Centricity PACS-IW-00001801, A2513980-Centricity PACS-IW-00040355, KW1019-Centricity PACS-IW-00115173, KW1018-Centricity PACS-IW-01422962, KW1003-Centricity PACS-IW-01798078, KW1001-Centricity PACS-IW-00164288, SSH-Centricity PACS-IW-01288660, PL2997-Centricity PACS-IW-00038793, PL1803-Centricity PACS-IW-00038812, PL1006-Centricity PACS-IW-00038821, PL1822-Centricity PACS-IW-00038825, TBD-Centricity PACS-IW-01273193, RU1241-Centricity PACS-IW-01273216, RU1493-Centricity PACS-IW-01273220, TBD-Centricity PACS-IW-01273244, RU2420-Centricity PACS-IW-01273234, RU3262-Centricity PACS-IW-01273245, RU6248-Centricity PACS-IW-01273279, RU8052-Centricity PACS-IW-02337508, RU8071-Centricity PACS-IW-01273295, -Centricity PACS-IW-01273233, RU7576-Centricity PACS-IW-01273287, RU3880-Centricity PACS-IW-01273266, RU2527-Centricity PACS-IW-01273235, RU2878-Centricity PACS-IW-01273243, TBD-Centricity PACS-IW-01273306, TBD-Centricity PACS-IW-01273258, RU5499-Centricity PACS-IW-01273278, RU1279-Centricity PACS-IW-02337628, RU1469-Centricity PACS-IW-01273219, TBD-Centricity PACS-IW-01273200, RU8321-Centricity PACS-IW-01273303, RU1130-Centricity PACS-IW-01273210, RU7426-Centricity PACS-IW-01273284, TBD-Centricity PACS-IW-01273262, TBD-Centricity PACS-IW-01273224, RU8953-Centricity PACS-IW-01273311, RU2367-Centricity PACS-IW-01273232, RU1026-Centricity PACS-IW-01273195, TBD-Centricity PACS-IW-01273198, RU8036-Centricity PACS-IW-01273293, RU7564-Centricity PACS-IW-01273286, RU3476-Centricity PACS-IW-01273251, RU3610-Centricity PACS-IW-01273257, RU1028-Centricity PACS-IW-01273197, RU1022-Centricity PACS-IW-01273194, RU5442-Centricity PACS-IW-01273277, RU3883-Centricity PACS-IW-01273267, RU3467-Centricity PACS-IW-01273250, RU3663-Centricity PACS-IW-01273259, RU7905-Centricity PACS-IW-01273291, TBD-Centricity PACS-IW-01273256, TBD-Centricity PACS-IW-01273296, RU7838-Centricity PACS-01273289, TBD-Centricity PACS-IW-01273218, RU8607-Centricity PACS-IW-01273308, ZA2470-Centricity PACS-IW-00116572, ZA2352-Centricity PACS-IW-00116570, ZA2471-Centricity PACS-IW-00116573, ZA2351-Centricity PACS-IW-00116569, ZA2356-Centricity PACS-IW-00116576, ZA2355-Centricity PACS-IW-00116575; g) 2052829-001, No UDI/DI, Product ID Numbers: 4300-1-Centricity PACS-IW-00558207; h) Not applicable, No UDI/DI, Product ID Numbers: N/A, Product ID Numbers: 2336375-Centricity PACS-IW-15773150
- Recall started
- March 28, 2023
- Device type
- System, Image Processing, Radiological
- Root cause (FDA)
- Other
- What the company told customers
- GE issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/28/2023 by mail (traceable means). The notice explained the issue and the risk, and provideed safety instructions for continued use of the device. GE HealthCare will address this issue through a software correction.
- Recall number
- Z-1502-2023
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1500-2023, Z-1501-2023, Z-1502-2023. The agency record governs; check it and the company before acting.