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.
FDA Recall Z-1486-2025 · Posted 2025-03-28
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Recalling FirmGE Healthcare
Recall StatusOpen, Classified
Product CodeLLZ
Date Initiated2025-02-19
Product Quantity633 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.
Firm Action
GE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 02/19/2025 by letter delivered using traceable means. The notice explained the issue, safety issue, and requested the following actions be taken:
"You can continue to use your device.
Please ensure all potential users in your facility are made aware of this safety notification.
Please ensure you have implemented the actions below:
1: Ensure your hospital network is secure
and
2: Outside of the hospital network implement additional safeguards such as a VPN.
Please retain this document for your records.
Please complete and return the attached acknowledgement form to [email protected]."
"If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative."
Per status report 05/23/2025, the firm send a follow-up notice dated 05/13/2025 providing an installation manual addendum that provides instructions for changing passwords.
Root Cause
Software design
Distribution Pattern
Worldwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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