GE Centricity Universal Viewer Zero Footprint Client
Hazard
There is a potential to display incomplete patient imaging study.
What You Should Do
Remedy
The firm issued medical device correction letters dated 10/15/2021 on the same date via traceable means. The letter described the safety issue and actions to be taken. The letter informed the consignee they can continue to use the device by following the instructions provided in the letter until a GE Service Representative can restart their ZFP system.
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Products
GE Centricity Universal Viewer Zero Footprint Client
- Brand
- GE Healthcare, LLC
- UPC
- Versions 6.0 SP9, SP9.0.1, SP9.0.1.1, SP9.0.1.2, SP9.0.1.3, SP9.0.1.4, SP9.0.1.5, SP10, SP10.1, SP10.2, SP10.2.1, SP10.2.1.1, SP10.2.2, SP10.2.2.1 configured with a Centricity PACS back end. GTIN 00840682102988; UDI 00840682102988.
Units Affected
638 devices