GE Healthcare: Device Recall
Recall #Z-1486-2025 · 02/19/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1486-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- GE Healthcare
- Status
- Ongoing
- Date Initiated
- 02/19/2025
- Location
- Chicago, IL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 633 units
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.
Product Description
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001; 2) 2038437-001; 3) 2038437-009; 4) 2038437-014; 5) 2038437-015 ; 6) 2038437-0XX; 7) 2109571-007; 8) 2109571-010; 9) 2109571-011; 10) 2109571-012; 11) MANLEGACY111; 12) MANLEGACY112; 13) MANLEGACY47; 14) P00011TS.
Distribution Pattern
Worldwide distribution.
Other Recalls by GE Healthcare
- Class II: Risk 02/19/2025
- Class II: Risk 02/19/2025
- Class II: Risk 02/19/2025
- Class II: Risk 02/19/2025
- Class II: Risk 10/03/2024
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.