—#189064

Product

Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K182419
Affected lot / code info: Centricity Universal Viewer, Software Versions 7.0 SP0.0.4.5 and 7.0 SP0.0.5 GTIN 00840682145794

Why it was recalled

A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).

Root cause (FDA determination)

Other

Action the firm took

This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected software versions on August 13, 2021. This letter informs customers of the issues and provides safety instructions. GE Healthcare will correct the issue through a product change. 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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: AR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France, Germany, India, Japan, Korea, Kuwait, Saudi Arabia, Singapore, Switzerland, Switzerland, Turkey and United Kingdom

Timeline

Recall initiated: 2021-08-12
Posted by FDA: 2021-10-02
Terminated: 2024-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #189064. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.