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U.S. Department of Health and Human Services

Class 2 Device Recall Centricity Universal Viewer 6.0

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 Class 2 Device Recall Centricity Universal Viewer 6.0see related information
Date Initiated by FirmJanuary 30, 2026
Date PostedMarch 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1571-2026
Recall Event ID 98428
510(K)NumberK123174 
Product Classification System, image processing, radiological - Product Code LLZ
ProductCentricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
Code Information Product ID Numbers: 4446-2-Centricity Universal Viewer-00558643 100256-3-Centricity Universal Viewer-00558700 101044-1-Centricity Universal Viewer-00558694 13240-2-Centricity Universal Viewer-00558103 4441-1-Centricity Universal Viewer-00558677 4578-1-Centricity Universal Viewer-00558340 10831-2-Centricity Universal Viewer-00558682 656341-Centricity Universal Viewer-01431499 50567-Centricity Universal Viewer-02176369 2690973-Centricity Universal Viewer-01454622 EG1526-Centricity Universal Viewer-00158976 A91901-Centricity Universal Viewer-00044549 M3488569-Centricity Universal Viewer-00071707 25540620 - HC4105-Centricity Universal Viewer-00001393 416005-Centricity Universal Viewer-00260808 1868708X - 556162-Centricity Universal Viewer-00157857 HKOB01-Centricity Universal Viewer-01282268 BMH-Centricity Universal Viewer-01820534 JIPMER-Centricity Universal Viewer-01820555 4347967-Centricity Universal Viewer-01474540 651342-Centricity Universal Viewer-01365218 651342-Centricity Universal Viewer-01365213 A3431341-Centricity Universal Viewer-00545677 473265-Centricity Universal Viewer-01442014 JP-131575-Centricity Universal Viewer-01275307 442900-Centricity Universal Viewer-01460668 577127-Centricity Universal Viewer-01444349 349551-Centricity Universal Viewer-02350518 PL3277-Centricity Universal Viewer-00038831 RU3866-Centricity Universal Viewer-01445731 RU8945-Centricity Universal Viewer-01445740 RU2580-Centricity Universal Viewer-01445743 1354732-Centricity Universal Viewer-01273292 RU3453-Centricity Universal Viewer-01273249 SA2160-Centricity Universal Viewer-00111827 SA1208-Centricity Universal Viewer-00066587 882983-Centricity Universal Viewer-02277629 ZA2533-Centricity Universal Viewer-00116577
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionAn 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.
Quantity in Commerce40 units
DistributionWorldwide - US Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = LLZ
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