FDA Medical devices recall ·
GE Healthcare Centricity Radiology RA600 (RA600)… recall
- Recall number
- Z-1485-2025
- 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
- 1563 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
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 # 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; Model/Catalog/Code # 2033901-001, Installed Product ID 103634-5-Centricity RA600-00099545, UDI UDI Not Required, System ID 520784RA6CLSW3; Model/Catalog/Code # 2033901-001, Installed Product ID 104027-1-Centricity RA600-00102852, UDI UDI Not Required, System ID 928729RA600SW2; Model/Catalog/Code # 2033901-0
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-1485-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.