—#212701

Product

GE Healthcare Centricity Centricity PACS-IW with Universal Viewer, Model Numbers: 1) 2049587-015; 2) 2066908-086; 3) 2066908-136; 4) 2104867-045.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
Affected lot / code info: 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.

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 500 W Monroe St, Chicago, Illinois 60661-3671

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2025-02-19
Posted by FDA: 2025-03-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212701. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.