GE Healthcare: Device Recall

Recall #Z-1485-2025 · 02/19/2025

Class II: Risk

Recall Details

Recall Number
Z-1485-2025
Classification
Class II
Product Type
Device
Recalling Firm
GE Healthcare
Status
Ongoing
Date Initiated
02/19/2025
Location
Chicago, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1563 units

Reason for Recall

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.

Product Description

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.

Distribution Pattern

Worldwide distribution.

Other Recalls by GE Healthcare

View all recalls by GE Healthcare →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.