Recall Z-1483-2025
GE Healthcare · initiated February 19, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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) 2088026-806; 21) 2088026-906; 22) 2088026-936; 23) 2088026-940; 24) 2088026-943; 25) 2088026-946; 26) 2088026-948; 27) 2088026-957; 28) 2088026-959; 29) 2088026-960; 30) 2088026-961; 31) 2088026-962; 32) 2088026-967; 33) 2088026-969; 34) 2088026-970; 35) 2088026-971; 36) 2088026-973; 37) 2088026-985; 38) 2088026-989; 39) 2088026-990; 40) 2088026-993; 41) 2088026-994; 42) 2089629-003; 43) 2100169-001; 44) 2100491-006; 45) 2100491-012; 46) 2102675-010; 47) 2102675-101; 48) 2102676-001; 49) 2104867-001; 50) 2104867-044; 51) 2104867-045; 52) 2111141-004; 53) 5826659-002; 54) 5826659-013; 55) 5826659-014; 56) 5826659-016; 57) 5826659-017; 58) 5826659-018; 59) 5826659-019; 60) 5826659-021; 61) 5826659-022; 62) 5826659-023; 63) 5826659-025; 64) 5826659-026; 65) 5826659-027; 66) 5826659-028; 67) 5826659-029; 68) 5826659-030; 69) 5826659-032; 70) 5826659-033; 71) K1220JWED; 72) K2042VJED.
Codes / lots: Model/Catalog/code # 2066908-077, Installed Product ID 000346895-Centricity Universal Viewer-01804910, UDI UDI Not Required, System ID HCIT1584981UV; Model/Catalog/code # 2066908-077, Installed Product ID 3444574-Centricity Universal Viewer-19417270, UDI UDI Not Required, System ID RSMKG-SERPONG02; Model/Catalog/code # 2066908-136, Installed Product ID 280801-Centricity Universal Viewer-19737221, UDI UDI Not Required, System ID HCIT1545332UVCTRL; Model/Catalog/code # 2066908-136, Installed Product ID 651342-Centricity Universal Viewer-01365218, UDI UDI Not Required, System ID RSPBINTARO3; Model/Catalog/code # 2066908-136, Installed Product ID 265719-Centricity Universal Viewer-01455055, UDI UDI Not Required, System ID HCIT4376494UV; Model/Catalog/code # 2066908-150, Installed Product ID KE2701-DF UV 50K BASE-00394965, UDI UDI Not Required, System ID KE2701UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE0301-Centricity Universal Viewer-00116859, UDI UDI Not Required, System ID KE0301UV01; Model/Catalog/code # 2066908-150, Installed Product ID KE4102-Centricity Universal Viewer-01402658, UDI UDI Not Required, System ID KE4102UW02; Model/Catalog/code # 2066908-150…
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.
FDA-determined cause: Software design
Action taken
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 recall.85480@gehealthcare.com." "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.
Details
- Recall number
- Z-1483-2025
- Initiated
- February 19, 2025
- Posted by FDA
- March 28, 2025
- Product code
- LLZ – System, Image Processing, Radiological
- Quantity
- 2653 units
- Distribution
- Worldwide distribution.
- Recalling firm
- GE Healthcare, Chicago, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1484-2025 Class II | GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | 02/19/2025Open, Classified |
| Z-1485-2025 Class II | GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | 02/19/2025Open, Classified |
| Z-1486-2025 Class II | GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | 02/19/2025Open, Classified |
| Z-1487-2025 Class II | GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | 02/19/2025Open, Classified |