Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
Enforcement
- Recall Number
- Z-0138-2024
- Event ID
- 93099
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Healthcare
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 1, 2023
- Initiation Date
- September 14, 2023
- Classification Date
- October 20, 2023
- Address
- 500 W Monroe St, N/A, Chicago, IL, 60661-3671, United States
Description
Centricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Processing System
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.
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
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
149 units