Recall Z-1485-2025
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 Radiology RA600 (RA600), Model Numbers: 1) 2022296-001; 2) 2033901-001; 3) 2038437-001; 4) 2038437-011; 5) 2038437-012; 6) 2038437-013; 7) 2038437-014; 8) 2038437-0XX; 9) 2098071-004; 10) 2109571-002; 11) 2109571-006; 12) 2109571-010; 13) 2109594-009; 14) 2109594-011; 15) K2090PS; 16) K2090PTED; 17) MANLEGACY114; 18) MANLEGACY64.
Codes / lots: Model/Catalog/Code # 2022296-001, Installed Product ID 103889-1-Centricity RA600-01461073, UDI UDI Not Required, System ID NDMGRA01; Model/Catalog/Code # 2022296-001, Installed Product ID AH5045-Centricity RA600-00000127, UDI UDI not required, System ID AH5045RW01; Model/Catalog/Code # 2022296-001, Installed Product ID AP0701-Centricity RA600-00000173, UDI UDI not required, System ID AP0701RW01; Model/Catalog/Code # 2022296-001, Installed Product ID 50451-Centricity RA600-02351785, UDI UDI Not Required, System ID HCIT1169080RA600; Model/Catalog/Code # 2022296-001, Installed Product ID 519926-Centricity RA600-00000672, UDI UDI Not required, System ID 519926RW01; Model/Catalog/Code # 2022296-001, Installed Product ID A51043-Centricity RA600-00040985, UDI UDI Not required, System ID A51043117; Model/Catalog/Code # 2022296-001, Installed Product ID 549858-Centricity RA600-01286184, UDI UDI Not Required, System ID MJ1; Model/Catalog/Code # 2022296-001, Installed Product ID RW602-Centricity RA600-00005819, UDI UDI not required, System ID RW60200083; Model/Catalog/Code # 2022296-001, Installed Product ID 80115-Centricity RA600-00005736, UDI UDI not required, System ID 60115TRS01…
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-1485-2025
- Initiated
- February 19, 2025
- Posted by FDA
- March 28, 2025
- Product code
- LLZ – System, Image Processing, Radiological
- Quantity
- 1563 units
- Distribution
- Worldwide distribution.
- Recalling firm
- GE Healthcare, Chicago, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1483-2025 Class II | GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2)…There is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW… | 02/19/2025Open, Classified |
| 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-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 |