FDA Device recall Z-1484-2025
GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001 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-1484-2025 |
| 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 PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; 3) 2049587-011; 4) 2049587-012; 5) 2049587-015; 6) 2049588-012 ; 7) 2052829-001.
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 # 2042988-001, Installed Product ID 707509-Centricity PACS-IW-01452391, UDI UDI Not Required, System…Model/Catalog/Code # 2042988-001, Installed Product ID 707509-Centricity PACS-IW-01452391, UDI UDI Not Required, System ID HCIT4250187IW; Model/Catalog/Code # 2042988-001, Installed Product ID 613493-Centricity PACS-IW-02292544, UDI UDI Not Required, System ID HCIT4507688PACS; Model/Catalog/Code # 2049587-009, Installed Product ID 4276-1-Centricity PACS-IW-00558274, UDI UDI Not Required, System ID PACS-IW-168; Model/Catalog/Code # 2049587-011, Installed Product ID 12830-1-Centricity PACS-IW-00558312, UDI UDI Not Required, System ID PACS-IW-477; Model/Catalog/Code # 2049587-011, Installed Product ID 4352-1-Centricity PACS-IW-00558316, UDI UDI Not Required, System ID PACS-IW-89; Model/Catalog/Code # 2049587-012, Installed Product ID 100858-1-Centricity PACS-IW-00558426, UDI UDI Not Required, System ID PACS-IW-412; Model/Catalog/Code # 2049587-012, Installed Product ID 4294-1-Centricity PACS-IW-00558379, UDI UDI Not Required, System ID PACS-IW-304; Model/Catalog/Code # 2049587-012, |
|---|
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-1484-2025%22
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