Centricity recallZ-1487-2025 · GE Healthcare · initiated Feb 19, 2025
Class II Open, Classified All recalls posted in March 2025
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Software design
What the company is doing
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken: "You can continue to use your device. Please ensure all potential users in your facility are made aware of this safety notification. Please ensure you have implemented the actions below: 1: Ensure your hospital network is secure and 2: Outside of the hospital network implement additional safeguards such as a VPN. Please retain this document for your records. Please complete and return the attached acknowledgement form to [email protected]." "If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative." Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
Recall details
- Recall number
- Z-1487-2025
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 19, 2025
- Posted by the FDA
- Mar 28, 2025
- Recalling firm
- GE Healthcare
- Quantity
- 4 units
- Product code
- LLZ
- Distribution
- Worldwide distribution.
Product description
GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CENTRICITY UNIVERSAL VIEWER 6.0Ge Healthcare · System, image processing, radiological8 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96375).
- Z-1483-2025 · Open, ClassifiedGE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908-136; 3) 2066908-150; 4) 2088026-003; 5) 2088026-026; 6) 2088026-032; 7) 2088026-043;…
- Z-1485-2025 · Open, ClassifiedGE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-…
- Z-1486-2025 · Open, ClassifiedGE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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