CLASS II ONGOING Device recall · Reported 10 May 2023 · FDA Enforcement Report
Centricity Pacs-iw with Universal Viewer recalled by GE Healthcare
GE Healthcare is recalling Centricity Pacs-iw with Universal Viewer. The recall was initiated on 28 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1500-2023
- FDA event ID
- 92062
- Recalling firm
- GE Healthcare, Chicago, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 28 Mar 2023
- FDA classified
- 2 May 2023
- Reported
- 10 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Mar 2023 | Recall initiated by company | |
| 2 May 2023 | Classified by FDA | +35 days |
| 10 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution
Questions about this recall
Why was it recalled?
GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information.
Which lots are affected?
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-Centricity Universal Viewer-00558264, 3727-1-Centricity Universal Viewer-00558421, RU9761-UW PACS-IW UP TO 10K-02336112
Where was it sold?
Worldwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 92062| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Universal Viewer, Centricity Universal Viewer recalled | GE Healthcare | Other | IL | |
| CLASS II | Centricity Pacs-iw, Product ID Numbers: a) recalled by GE Healthcare | GE Healthcare | Other | IL |
More recalls from GE Healthcare
All 518| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Enterprise Archive V8 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Workflow Core Services V8, intended to provide set recalled | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Core Services Hub V8, a set of backend services including recalled | GE Healthcare | Other | Nationwide |
| Device | CLASS II | Centricity Enterprise Archive V2, V3, and V4 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Centricity PACS V2, V3, V4, V6, V7 recalled by GE Healthcare | GE Healthcare | Device Malfunction | Nationwide |
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