Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including

FDA device recall Z-1569-2026 · posted 2026-03-16 · Open, Classified

Recall details

Recalling firm

GE Medical Systems, LLC

Reason for recall

There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.

Action taken

An URGENT MEDICAL DEVICE CORRECTION notification letter dated 1/30/26 was sent to customers. Actions to be taken by Customer/User Pending corrections from GE HealthCare, you can continue using your device by following the instructions below: Ensure workstations have appropriate security controls per product manuals. Implement network account authentication by using Active Directory/LDAP services for user management. If network account authentication is not possible at your site, please contact GE HealthCare Service to request temporary steps to mitigate the issue. Ensure all potential users in your facility are informed of this safety notification. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.85491@gehealthcare.com. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange the correction. 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.

Root cause

Software design

Status

Open, Classified

Product code

LLZ

Quantity affected

1568 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2026-01-30

Date posted

2026-03-16

Location

Waukesha, WI

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