FDA · Medical device recall

Centricity PACS-IW… and 2 more products

Nov. 1, 2023 Class II

Date: Nov. 1, 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 images from two different patients may be contained in a single study, when stored in Centricity PACS-IW V3.7.x, Centricity PACS-IW with Universal Viewer V5.0 and Centricity Universal Viewer V6.0 with PACS-IW foundation.
Distribution pattern: US and Austria, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, Chile, Colombia, France, Germany, India, Ireland, Italy, Kuwait, Malaysia, Netherlands, Netherlands Antilles, Panama, Poland, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, Uruguay, Venezuela, Vietnam

3 products in this recall

Centricity PACS-IW…

Product: Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Quantity: 149 units
Codes and lots: UDI/DI none, Installed Product ID #: 101792-1-Centricity PACS-IW-00558370, 4345-1-Centricity PACS-IW-00558548, 12830-1-Centricity PACS-IW-00558312, 4378-1-Centricity PACS-IW-00558498, 100663-1-Centricity PACS-IW-00558514, 100858-1-Centricity PACS-IW-00558426, 100702-1-Centricity PACS-IW-00558539, 4109-1-Centricity PACS-IW-00558389, 101625-1-Centricity PACS-IW-00558531, 4593-1-Centricity PACS-IW-00558488, 100009-1-Centricity PACS-IW-00558560, 100838-1-Centricity PACS-IW-00558532, 4300-1-Centricity PACS-IW-00558207, 4294-1-Centricity PACS-IW-00558379, 13039-1-Centricity PACS-IW-00558385, 13102-1-Centricity PACS-IW-00558512, 4694-1-Centricity PACS-IW-00558556, 101742-1-Centricity PACS-IW-00558470, 101883-1-Centricity PACS-IW-00558487, 9791-1-Centricity PACS-IW-00558418, 11764-1-Centricity PACS-IW-00558388, 101689-1-Centricity PACS-IW-00558326, 4744-1-Centricity PACS-IW-00558373, 4358-1-Centricity PACS-IW-00558564, 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, 13095-1-Centricity PACS-IW-00558534, 4326-4-Centricity PACS-IW-00558105, 4352-1-Centricity PACS-IW-00558316, 4443-1-Centricity PACS-IW-00558167, 4374-1-Centricity PACS-IW-00558422, 4301-1-Centricity PACS-IW-00558525, 2387-1-Centricity PACS-IW-00558489, 4277-1-Centricity PACS-IW-00558474, 100802-1-Centricity PACS-IW-00558540, 101216-1-Centricity PACS-IW-00558356, 101193-1-Centricity PACS-IW-00558551, 101240-1-Centricity PACS-IW-00558425, 4661-1-Centricity PACS-IW-00558528, 3943-1-Centricity PACS-IW-00558501, 4361-1-Centricity PACS-IW-00558343, 12949-1-Centricity PACS-IW-00558442, 4276-1-Centricity PACS-IW-00558274, 4383-1-Centricity PACS-IW-00558533, 13233-3-Centricity PACS-IW-00558554, 12974-1-Centricity PACS-IW-00558300, 4393-1-Centricity PACS-IW-00558328, 4482-1-Centricity PACS-IW-00558281, 4389-1-Centricity PACS-IW-00558563, 100645-1-Centricity PACS-IW-14764451, 4573-1-Centricity PACS-IW-00558420, 4506-1-Centricity PACS-IW-00558345, AZ4030-Centricity PACS-IW-02336621, BA4080-Centricity PACS-IW-00038769, 707509-Centricity PACS-IW-01452391, 324462-Centricity PACS-IW-01431554, 613493-Centricity PACS-IW-02292544, 302144-Centricity PACS-IW-01421157, 246838-Centricity PACS-IW-01421153, 213537-Centricity PACS-IW-01431510, 319674-Centricity PACS-IW-01431535, 280801-Centricity PACS-IW-01431490, 320090-Centricity PACS-IW-01444604, 307319-Centricity PACS-IW-01444609, SiteID-Centricity PACS-IW-01572187, RMUE01-Centricity PACS-IW-00001801, StThomas-Centricity PACS-IW-01819447, HOLY-FAMILY-THODU-Centricity PACS-IW-01821493, WOCKHARDT-Centricity PACS-IW-01819449, SIMS-Centricity PACS-IW-01819453, MARTHANDAM-Centricity PACS-IW-01819446, CONTINENTAL-Centricity PACS-IW-01819443, A2513980-Centricity PACS-IW-00040355, KW1019-Centricity PACS-IW-00115173, KW1112-Centricity PACS-IW-00168151, 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, PL1825-Centricity PACS-IW-00038819, 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, RU2580-Centricity PACS-IW-01273240, RU2527-Centricity PACS-IW-01273235, RU3382-Centricity PACS-IW-01273247, RU2878-Centricity PACS-IW-01273243, TBD-Centricity PACS-IW-01273306, TBD-Centricity PACS-IW-01273258, RU5499-Centricity PACS-IW-01273278, RU3680-Centricity PACS-IW-01273260, 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, RU3380-Centricity PACS-IW-01273246, 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, 14335625-Centricity PACS-IW-20614918, ONCOLOGY-Centricity PACS-IW-01288658
Recall started: Sept. 14, 2023
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 09/14/2023 by letter. The notice explained the problem, risk to the patient, and provided two workaround options for the continued use of the instruments until the software update is ready for installation. Questions: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative
Recall number: Z-0138-2024

Centricity PACS-IW with Universal Viewer…

Product: Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiological Image Processing System
Quantity: 17 units
Codes and lots: UDI/DI none, Installed Product ID #: 100707-1-Centricity Universal Viewer-00558649, 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785, 100759-1-Centricity Universal Viewer-02360986, 9842-4-Centricity Universal Viewer-19386293, 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 4705-1-Centricity Universal Viewer-02398923, 100512-1-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, HC3062-Centricity Universal Viewer-01462397, RU9761-UW PACS-IW UP TO 10K-02336112, ZA2533-Centricity Universal Viewer-00116577, YP3150-Centricity Universal Viewer-01639018
Recall started: Sept. 14, 2023
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 09/14/2023 by letter. The notice explained the problem, risk to the patient, and provided two workaround options for the continued use of the instruments until the software update is ready for installation. Questions: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative
Recall number: Z-0139-2024

Centricity Universal Viewer…

Product: Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Image Processing System
Quantity: 329 units
Codes and lots: UDI/DI 840682103800, Installed Product ID #: 102123-1-Centricity Universal Viewer-00558570, 102123-1-Centricity Universal Viewer-02157634, 1011-1-Centricity Universal Viewer-00558109, 1011-1-Centricity Universal Viewer-02097166, 1011-1-Centricity Universal Viewer-02097165, 100666-1-Centricity Universal Viewer-14194768, 100666-1-Centricity Universal Viewer-20084199, 9789-1-Centricity Universal Viewer-00558645, 4413-2-Centricity Universal Viewer-02288447, 4267-5-Centricity Universal Viewer-19618406, 100763-1-Centricity Universal Viewer-00558366, 101171-1-Centricity Universal Viewer-02398531, 101171-1-Centricity Universal Viewer-02398531, 104535-3-Centricity Universal Viewer-02396026, 104535-3-Centricity Universal Viewer-02396027, 104535-3-Centricity Universal Viewer-02396028, 104535-3-Centricity Universal Viewer-02396029, 11438-1-Centricity Universal Viewer-00558464, 104535-4-Centricity Universal Viewer-02396030, 104535-4-Centricity Universal Viewer-01806096, 4415-1-Centricity Universal Viewer-00558359, 4415-1-Centricity Universal Viewer-01973510, 4308-1-Centricity Universal Viewer-00558676, 4308-1-Centricity Universal Viewer-21200827, 4308-1-Centricity Universal Viewer-21200830, 4318-1-Centricity Universal Viewer-00558703, 4318-1-Centricity Universal Viewer-20080694, 4048-1-Centricity Universal Viewer-00558695, 4048-1-Centricity Universal Viewer-14767809, 4048-1-Centricity Universal Viewer-14767808, 4048-1-Centricity Universal Viewer-14767807, 4048-1-Centricity Universal Viewer-14767806, 4048-1-Centricity Universal Viewer-02256595, 4460-1-Centricity Universal Viewer-02255583, 4460-1-Centricity Universal Viewer-01819618, 4460-7-Centricity Universal Viewer-02255586, 4460-7-Centricity Universal Viewer-02255587, 101280-1-Centricity Universal Viewer-19630914, 101280-1-Centricity Universal Viewer-19630915, 101280-1-Centricity Universal Viewer-19630916, 101280-1-Centricity Universal Viewer-20553950, 9768-1-Centricity Universal Viewer-00558661, 9768-1-Centricity Universal Viewer-01972254, 4552-1-Centricity Universal Viewer-01294074, 6579-11-Centricity Universal Viewer-02339896, 4353-2-Centricity Universal Viewer-01589220, 4698-1-Centricity Universal Viewer-00558313, 100029-1-Centricity Universal Viewer-02256808, 100717-1-Centricity Universal Viewer-01293807, 100717-1-Centricity Universal Viewer-01293808, 13162-8-Centricity Universal Viewer-01452133, 13162-8-Centricity Universal Viewer-14776447, 13162-8-Centricity Universal Viewer-14776449, 100019-1-Centricity Universal Viewer-00558666, 100019-1-Centricity Universal Viewer-01477448, 100019-1-Centricity Universal Viewer-01477447, 100019-1-Centricity Universal Viewer-15993728, 101725-2-Centricity Universal Viewer-00558642, 4687-1-Centricity Universal Viewer-00558334, 100489-1-Centricity Universal Viewer-01819402, 100489-1-Centricity Universal Viewer-20791988, 104249-1-Centricity Universal Viewer-00558667, 104287-2-Centricity Universal Viewer-00555505, 4451-1-Centricity Universal Viewer-00558107, 100366-1-Centricity Universal Viewer-00558522, 100366-1-Centricity Universal Viewer-14777071, 100718-2-Centricity Universal Viewer-02350739, 100718-1-Centricity Universal Viewer-02373799, 4742-2-Centricity Universal Viewer-01766912, 4742-2-Centricity Universal Viewer-20584004, 4742-2-Centricity Universal Viewer-20685485, 4583-1-Centricity Universal Viewer-01367198, 12968-1-Centricity Universal Viewer-02277843, 12968-1-Centricity Universal Viewer-02278145, 2337-5-Centricity Universal Viewer-01810490, 2337-5-Centricity Universal Viewer-19670358, 12902-1-Centricity Universal Viewer-00602638, 3245-1-Centricity Universal Viewer-01451973, 4585-3-Centricity Universal Viewer-01448365, 4585-3-Centricity Universal Viewer-20502096, 101039-1-Centricity Universal Viewer-01373579, 101039-1-Centricity Universal Viewer-14580319, 13345-1-Centricity Universal Viewer-00602707, 9852-2-Centricity Universal Viewer-00558644, 9852-2-Centricity Universal Viewer-02267839, 9852-2-Centricity Universal Viewer-01271417, 1530-1-Centricity Universal Viewer-00558491, 1530-12-Centricity Universal Viewer-01301357, 9764-1-Centricity Universal Viewer-01722652, 4391-1-Centricity Universal Viewer-02205222, 4391-3-Centricity Universal Viewer-01459013, 4698-11-Centricity Universal Viewer-19667347, 4698-11-Centricity Universal Viewer-15961473, 100159-1-Centricity Universal Viewer-00558324, 13295-1-Centricity Universal Viewer-01292684, 13295-1-Centricity Universal Viewer-19609993, 13295-1-Centricity Universal Viewer-19611189, 101598-1-Centricity Universal Viewer-00667138, 100971-1-Centricity Universal Viewer-00558469, 4382-1-Centricity Universal Viewer-02268547, 102768-1-Centricity Universal Viewer-02179353, 102768-1-Centricity Universal Viewer-02255613, 102768-1-Centricity Universal Viewer-16174584, 100636-1-Centricity Universal Viewer-01815255, 4637-1-Centricity Universal Viewer-00558372, 4637-1-Centricity Universal Viewer-02176556, 9094-1-Centricity Universal Viewer-01766830, 9094-1-Centricity Universal Viewer-01977629, 4433-1-Centricity Universal Viewer-00558704, 4433-1-Centricity Universal Viewer-17737529, 4682-1-Centricity Universal Viewer-02274840, 100864-1-Centricity Universal Viewer-00558400, 4669-1-Centricity Universal Viewer-00558691, 4669-1-Centricity Universal Viewer-14768587, 100104-1-Centricity Universal Viewer-16204735, 100104-1-Centricity Universal Viewer-01299102, 4440-1-Centricity Universal Viewer-00558353, 4440-1-Centricity Universal Viewer-02332746, 104491-1-Centricity Universal Viewer-01288014, 12961-1-Centricity Universal Viewer-00558236, 4449-1-Centricity Universal Viewer-00558276, 4449-1-Centricity Universal Viewer-20689478, 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, 4306-3-Centricity Universal Viewer-00558573, 4306-1-Centricity Universal Viewer-02263351, 4306-3-Centricity Universal Viewer-02345023, 4306-3-Centricity Universal Viewer-02288781, 4362-1-Centricity Universal Viewer-01299095, 4362-1-Centricity Universal Viewer-19732280, 100581-1-Centricity Universal Viewer-01814001, 100092-1-Centricity Universal Viewer-15531177, 100092-1-Centricity Universal Viewer-14767331, 100092-1-Centricity Universal Viewer-00558648, 100092-1-Centricity Universal Viewer-00558697, 8746-1-Centricity Universal Viewer-00558308, 8746-1-Centricity Universal Viewer-01448329, 1057-1-Centricity Universal Viewer-02180910, 1057-1-Centricity Universal Viewer-00558402, 1057-1-Centricity Universal Viewer-14961014, 104336-1-Centricity Universal Viewer-00346858, 101690-1-Centricity Universal Viewer-00558680, 101690-1-Centricity Universal Viewer-20091140, 13125-1-Centricity Universal Viewer-00558110, 13125-1-Centricity Universal Viewer-20497227, 4351-1-Centricity Universal Viewer-01627896, 4351-1-Centricity Universal Viewer-16023960, 101170-1-Centricity Universal Viewer-00558305, 4483-1-Centricity Universal Viewer-00558457, 4483-1-Centricity Universal Viewer-20583582, 4742-3-Centricity Universal Viewer-02182462, 9796-1-Centricity Universal Viewer-00558571, 100770-1-Centricity Universal Viewer-01804127, 9752-1-Centricity Universal Viewer-02393053, 9752-1-Centricity Universal Viewer-00558454, 13225-1-Centricity Universal Viewer-02032334, 100769-1-Centricity Universal Viewer-01298556, 100769-1-Centricity Universal Viewer-02395799, 2403-7-Centricity Universal Viewer-01973509, 100468-1-Centricity Universal Viewer-02287985, 100468-1-Centricity Universal Viewer-02288300, 12966-1-Centricity Universal Viewer-01283020, 12966-1-Centricity Universal Viewer-20025013, 4683-1-Centricity Universal Viewer-00558456, 4601-1-Centricity Universal Viewer-00558699, 101310-1-Centricity Universal Viewer-02039946, 4347-1-Centricity Universal Viewer-00558520, 4487-1-Centricity Universal Viewer-01291589, 4487-1-Centricity Universal Viewer-02097167, AH4325-Centricity Universal Viewer-00160202, AH5291-Centricity Universal Viewer-00394902, AP6264-Centricity Universal Viewer-00000180, AP6469-Centricity Universal Viewer-01816421, AH0116-Centricity Universal Viewer-00160203, AH0106-Centricity Universal Viewer-00160204, 613493-Centricity Universal Viewer-02175791, 313741-Centricity Universal Viewer-01422997, 313741-Centricity Universal Viewer-02097256, 313741-Centricity Universal Viewer-15591262, 000282202-Centricity Universal Viewer-02291736, 571064-Centricity Universal Viewer-01293639, A54852-Centricity Universal Viewer-00043560, M41980-Centricity Universal Viewer-00044515, HC0399-Centricity Universal Viewer-01282972, PC1695-Centricity Universal Viewer-01447701, 786787-Centricity Universal Viewer-01283171, HBON01-Centricity Universal Viewer-00260801, 691749-Centricity Universal Viewer-01539092, 509940-Centricity Universal Viewer-01813036, HC0529-Centricity Universal Viewer-01364776, 683198-Centricity Universal Viewer-02263377, HC0245-Centricity Universal Viewer-00059319, 600791-Centricity Universal Viewer-02099049, 427990-Centricity Universal Viewer-01813160, 485135-Centricity Universal Viewer-01447706, 2336375-Centricity Universal Viewer-01444341, HC1414-Centricity Universal Viewer-01814335, PC1961-Centricity Universal Viewer-00001720, PC0023-Centricity Universal Viewer-01282279, 531344-Centricity Universal Viewer-00000707, CC0154-Centricity Universal Viewer-01813738, 509585-Centricity Universal Viewer-01826272, 601860-Centricity Universal Viewer-01373156, HC0565-Centricity Universal Viewer-00545595, HC4357-Centricity Universal Viewer-02090320, TP0575-Centricity Universal Viewer-01825777, 81111-Centricity Universal Viewer-01286673, A59927-Centricity Universal Viewer-00040382, A61971-Centricity Universal Viewer-01891850, AMS39-Centricity Universal Viewer-00545606, 268034-Centricity Universal Viewer-18862276, PL3673-Centricity Universal Viewer-00038810, PL1494-Centricity Universal Viewer-00038799, PL2970-Centricity Universal Viewer-00038797, PL1124-Centricity Universal Viewer-00038795, PL1499-Centricity Universal Viewer-00038800, PL1501-Centricity Universal Viewer-00038802, PL1190-Centricity Universal Viewer-21245580, PL1961-Centricity Universal Viewer-01981010, PL2624-Centricity Universal Viewer-00038804, PL1005-Centricity Universal Viewer-02336290, 600062-Centricity Universal Viewer-02095166, PL3362-Centricity Universal Viewer-20631670, PL0326-Centricity Universal Viewer-02040892, PL2975-Centricity Universal Viewer-00162605, PL2971-Centricity Universal Viewer-00038808, RU9255-Centricity Universal Viewer-19727239, 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, RU8366-Centricity Universal Viewer-18045776, 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, RU1107-Centricity Universal Viewer-01813331, RU9216-Centricity Universal Viewer-01982768, 600101-Centricity Universal Viewer-01273190, RU1544-Centricity Universal Viewer-02330871, RU2526-Centricity Universal Viewer-02331246, RU5388-Centricity Universal Viewer-01719556, RU0994-Centricity Universal Viewer-02331254, RU3794-Centricity Universal Viewer-19673911, RU9226-Centricity Universal Viewer-19673912, RU6968-Centricity Universal Viewer-02335840, RU8356-Centricity Universal Viewer-01445768, RU9595-Centricity Universal Viewer-01812133, 600105-Centricity Universal Viewer-02331152, RU9697-Centricity Universal Viewer-19673913, 2422939-Centricity Universal Viewer-01509505, RU0120-Centricity…
Recall started: Sept. 14, 2023
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 09/14/2023 by letter. The notice explained the problem, risk to the patient, and provided two workaround options for the continued use of the instruments until the software update is ready for installation. Questions: please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative
Recall number: Z-0140-2024

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

Source: FDA · Medical device enforcement reports, recall numbers Z-0138-2024, Z-0139-2024, Z-0140-2024. The agency record governs; check it and the company before acting.

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