| | Class 2 Device Recall Centricity Universal Viewer 6.0 |  |
| Date Initiated by Firm | January 30, 2026 |
|---|
| Date Posted | March 16, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1570-2026 |
|---|
| Recall Event ID |
98428 |
| 510(K)Number | K150420 |
|---|
| Product Classification |
System, image processing, radiological - Product Code LLZ
|
| Product | Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906 |
|---|
| Code Information |
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Recalling Firm/
Manufacturer |
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
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| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
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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. |
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FDA Determined
Cause 2 | Software design |
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| Action | 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. |
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| Quantity in Commerce | 797 units |
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| Distribution | Worldwide - US Nationwide distribution. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = LLZ
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