Recall Z-1484-2025
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 PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
Codes / lots: Model/Catalog/Code # 2042988-001, Installed Product ID 707509-Centricity PACS-IW-01452391, UDI UDI Not Required, System ID HCIT4250187IW; Model/Catalog/Code # 2042988-001, Installed Product ID 613493-Centricity PACS-IW-02292544, UDI UDI Not Required, System ID HCIT4507688PACS; Model/Catalog/Code # 2049587-009, Installed Product ID 4276-1-Centricity PACS-IW-00558274, UDI UDI Not Required, System ID PACS-IW-168; Model/Catalog/Code # 2049587-011, Installed Product ID 12830-1-Centricity PACS-IW-00558312, UDI UDI Not Required, System ID PACS-IW-477; Model/Catalog/Code # 2049587-011, Installed Product ID 4352-1-Centricity PACS-IW-00558316, UDI UDI Not Required, System ID PACS-IW-89; Model/Catalog/Code # 2049587-012, Installed Product ID 100858-1-Centricity PACS-IW-00558426, UDI UDI Not Required, System ID PACS-IW-412; Model/Catalog/Code # 2049587-012, Installed Product ID 4294-1-Centricity PACS-IW-00558379, UDI UDI Not Required, System ID PACS-IW-304; Model/Catalog/Code # 2049587-012, Installed Product ID 13039-1-Centricity PACS-IW-00558385, UDI UDI Not Required, System ID PACS-IW-313; Model/Catalog/Code # 2049587-012, Installed Product ID 4744-1-Centricity PACS-IW-00558373, UDI UDI…
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-1484-2025
- Initiated
- February 19, 2025
- Posted by FDA
- March 28, 2025
- Product code
- LLZ – System, Image Processing, Radiological
- Quantity
- 82 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-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 |