Home / Recalls / GE Healthcare / Z-1502-2023

Z-1502-2023 Class II Ongoing

Recalled by GE Healthcare — Chicago, IL

FDA device recall Z-1502-2023 was initiated by GE Healthcare on March 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
March 28, 2023
Termination Date
N/A
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

Other recalls by GE Healthcare

  • Z-1767-2026 Class II — SIGNA Premier systems (February 27, 2026)
  • Z-1475-2026 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: (January 16, 2026)
  • Z-0935-2026 Class II — GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processin (November 3, 2025)
  • Z-1485-2025 Class II — GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-0 (February 19, 2025)
  • Z-1486-2025 Class II — GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 203390 (February 19, 2025)
  • Z-1483-2025 Class II — GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; (February 19, 2025)
  • Z-1487-2025 Class II — GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers (February 19, 2025)
  • Z-1484-2025 Class II — GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; (February 19, 2025)
  • Z-0318-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2 (October 3, 2024)
  • Z-0039-2025 Class II — GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/C (August 29, 2024)

FDA data resources