medical Class II Updated 2023-11-01

GE Healthcare recalls Universal Viewer Workflow Manager, Image processing radiolog

Recalled Product

Universal Viewer Workflow Manager, Image processing radiological system

Hazard / Issue

When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams, it could display information on a different patient than WFM and the Viewer.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI/DI 00195278379610, Software versions 7.0 SP1.1, 7.0 SP1, 7.0 SP0.0.5, 7.0 SP0.1.0. All product IDs with an affected software version are impacted.
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