Z-1502-2023 Class II Ongoing

Recalled by GE Healthcare — Chicago, IL

FDA device recall Z-1502-2023 was initiated by GE Healthcare on Mar 28, 2023 and is designated Class II. Reason for recall: GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. The recall status is ongoing. Affected quantity: 153 units.

Recall Details

Product Type
Devices
Report Date
May 10, 2023
Initiation Date
Mar 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
153 units

Product 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

Reason for Recall

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

Code 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

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1502-2023
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.