FDA Device recall Z-1485-2025
GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of GE Healthcare Centricity Radiology RA600 (RA600), Model Numbers: 1) 2022296-001 by Ge Healthcare, citing there is a potential security vulnerability in Centricity Universal Viewer (UV), Centricity PACS-IW (PACS-IW), Centricity Radiology RA600 (RA600), & Centricity Cardiology CA1000 (….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1485-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-02-19 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Healthcare |
| Distribution | n/a |
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.
Reason
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.
Identifiers
| code_info | Model/Catalog/Code # 2022296-001, Installed Product ID 103889-1-Centricity RA600-01461073, UDI UDI Not Required, System…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-Cent |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1485-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.