FDA Medical devices recall ·
GE Healthcare Centricity Cardiology CA1000 (CA1000)… recall
- Recall number
- Z-1486-2025
- Date
- (initiated February 19, 2025)
- Company / brand
- GE Healthcare
500 W Monroe St, Chicago, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 633 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog/Code # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, System ID HCIT4082079CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 11558-1-Centricity CA1000-00099550, UDI UDI Not Required, System ID 520855CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103987-1-Centricity CA1000-00102841, UDI UDI Not Required, System ID 928537CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 9990-1-Centricity CA1000-00101135, UDI UDI not required, System ID 661327CWS01; Model/Catalog/Code # 2038437-001, Installed Product ID 10318-1-Centricity CA1000-00105877, UDI UDI not required, System ID 818397CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 10994-1-Centricity CA1000-00102387, UDI UDI Not required, System ID 909464CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 102131-1-Centricity CA1000-00105886, UDI UDI not required, System ID 818409CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4161-1-Centricity CA1000-00105894, UDI UDI Not Required, System ID 818502CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 103743-1-Centricity CA1000-00099665, UDI UDI Not Required, System ID 559582CA1SW1; Model/Catalog/Code # 2038437-001, Installed Product ID 4408-2-Centricity CA1000-00101725, UDI UDI not required, System ID 714843CA1000; Model/Catalog/Code # 2038437-001, Installed Product ID 4532-4-Centricity CA1000-00107356, UDI UDI Not Required, System ID 310
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1486-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.