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
Enforcement
- Recall Number
- Z-1502-2023
- Event ID
- 92062
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- GE Healthcare
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 10, 2023
- Initiation Date
- March 28, 2023
- Classification Date
- May 2, 2023
- Address
- 500 W Monroe St, Chicago, IL, 60661-3671, United States
Description
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
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
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
Worldwide Distribution
153 units