CLASS II ONGOING Device recall · Reported 9 Apr 2025 · 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 19 Feb 2025 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-1487-2025
- FDA event ID
- 96375
- Recalling firm
- GE Healthcare, Chicago, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Feb 2025
- FDA classified
- 28 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 Feb 2025 | Recall initiated by company | |
| 28 Mar 2025 | Classified by FDA | +37 days |
| 9 Apr 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Product as listed by the FDA
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
Where it was distributed
Worldwide distribution.
Questions about this recall
Why was it recalled?
There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (CA1000) where the service login credentials are able to be identified which could allow a malicious actor with these credentials to access the system and potentially manipulate patient data.
Which lots are affected?
Model/catalog/code # 2049587-015, Installed Product ID 100707-1-Centricity Universal Viewer-00558649, UDI UDI Not Required, System ID PACS-IW-126; Model/catalog/code # 2066908-086, Installed Product ID 9842-4-Centricity Universal Viewer-19386293, UDI UDI Not Required, System ID GA001PACTRL01; Model/catalog/code # 2066908-136, Installed Product ID ZA2533-Centricity Universal Viewer-00116577, UDI UDI Not Required, System ID ZA2533PAC1; Model/catalog/code # 2104867-045, Installed Product ID X9003062 - HC3062-Centricity Universal Viewer-01462397, UDI (01)00840682103800(10)6.0SP50412094097001D, System ID HC3062UV01.
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
1 other product · FDA event 96375| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Centricity Pacs-iw (Pacs-iw) recalled by GE Healthcare | GE Healthcare | Other | IL |
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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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