FDA Device recall Z-1501-2023
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 208…
- FDA Device
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 208… by Ge Healthcare, citing GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1501-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-28 |
| Published | 2023-05-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
Product
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 2088026-003, b) 2088026-026, c) 2088026-032, d) 2088026-043, e) 2088026-044, f) 2088026-115, g) 2088026-132, h) 2088026-306, i) 2088026-308, j) 2088026-406, k) 2088026-506, l) 2088026-613, m) 2088026-713, n) 2088026-714, o) 2088026-723, p) 2099714-001, q) 2100169-001, r) 2100491-006, s) 2102675-010, t) 2102676-001, u) 2104867-044, v) 2104867-045; Radiological Image Processing System
Reason
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Identifiers
| code_info | a) 2088026-003, No UDI/DI, Product ID numbers: 233637-Centricity Universal Viewer-15773152; b) 2088026-026, No UDI/D…a) 2088026-003, No UDI/DI, Product ID numbers: 233637-Centricity Universal Viewer-15773152; b) 2088026-026, No UDI/DI, Product ID numbers: 4446-2-Centricity Universal Viewer-00558643, 4491-1-Centricity Universal Viewer-00558690, 100256-3-Centricity Universal Viewer-00558700, 100256-3-Centricity Universal Viewer-01810788, 102143-1-Centricity Universal Viewer-00558685, 101044-1-Centricity Universal Viewer-00558694, 13356-2-Centricity Universal Viewer-00558681, 102335-1-Centricity Universal Viewer-00558675, 13228-1-Centricity Universal Viewer-00558678, 101274-1-Centricity Universal Viewer-00558679, 101274-1-Centricity Universal Viewer-20279342, 13125-1-Centricity Universal Viewer-02268546, 102359-1-Centricity Universal Viewer-00558696, 4578-1-Centricity Universal Viewer-00558340, A54120-Centricity Universal Viewer-00040449, KW0000-Centricity Universal Viewer-01416913, BON01-Centricity Universal Viewer-00044131, PL3277-Centricity Universal Viewer-00038831; c) 2088026-032, No UDI/DI, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1501-2023%22
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