FDA Device recall Z-1486-2025
GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of GE Healthcare Centricity Cardiology CA1000 (CA1000), Model Numbers: 1) 2033901-001 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-1486-2025 |
| 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 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.
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 # 2033901-001, Installed Product ID 14335625-Centricity CA1000-19675863, UDI UDI Not Required, Syste…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Ge Healthcare
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distrib…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Adminis…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise im…
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare - Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
FDA Device · Class II · 2026-09-23 · Ge Healthcare
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1486-2025%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.