Recall Z-1483-2025 ยท LLZ System, Image Processing, Radiological
GE Healthcare
GE 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; 8) 2088026-110; 9) 2088026-115; 10) 2088026-132; 11) 2088026-306; 12) 2088026-308; 13) 2088026-406; 14) 2088026-506; 15) 2088026-614; 16) 2088026-713; 17) 2088026-714; 18) 2088026-715; 19) 2088026-723; 20)
| Date | Mar 28, 2025 (initiated Feb 19, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| Action | 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. Pleas |
| Quantity | 2653 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |