Reported Nov 1, 2023 · Ongoing
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
GE Healthcare
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare · 500 W Monroe St · Chicago, IL · 60661-3671
Is this the product you have?
- Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
- Lot codes and dates
- 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
- Amount recalled
- 149 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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