FDA Device recall Z-1500-2023
Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908…
- FDA Device
- Class II
- ongoing
- Published 2023-05-10
On 2023-05-10 the FDA classified a Class II recall of Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908… 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-1500-2023 |
| 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 PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 2066908-077, c) 2066908-086, d) 2066908-111, e) 2066908-123, f) 2066908-136, g) 2066908-150; 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 | No UDI/DI for these products: a) 2066908-061, Product ID Numbers: HC3062-Centricity Universal Viewer-01462397; b) 20…No UDI/DI for these products: a) 2066908-061, Product ID Numbers: HC3062-Centricity Universal Viewer-01462397; b) 2066908-077, Product ID Numbers: YP3150-Centricity Universal Viewer-01639018; c) 2066908-086, Product ID Numbers: 100707-1-Centricity Universal Viewer-00558649, 9842-4-Centricity Universal Viewer-19386293; d) 2066908-111, Product ID Numbers: 1045-1-Centricity Universal Viewer-00558651, 1045-1-Centricity Universal Viewer-19607785; e) 2066908-123, Product ID Numbers: 4705-1-Centricity Universal Viewer-02398923; f) 2066908-136, Product ID Numbers: 4723-1-Centricity Universal Viewer-02303576, 104648-2-Centricity Universal Viewer-02354806, 101272-1-Centricity Universal Viewer-00558671, ZA2533-Centricity Universal Viewer-00116577, 280801-Centricity Universal Viewer-19737221; g) 2066908-150, Product ID Numbers: 100759-1-Centricity Universal Viewer-02360986, 100713-1-Centricity Universal Viewer-00558259, 100713-1-Centricity Universal Viewer-01982629, 100512-1-Ce |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Ge Healthcare
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Adminis…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise im…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1500-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.