GE Healthcare Universal Viewer Workflow Manager, Image processing radiological system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Universal Viewer Workflow Manager, Image processing radiological system
Brand
GE Healthcare
Lot Codes / Batch Numbers
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.
Products Sold
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.
GE Healthcare is recalling Universal Viewer Workflow Manager, Image processing radiological system due to When using Universal Viewer or Centricity Universal Viewer with Workflow Manager (WFM), if a third-party reporting application is used to launch exams. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
GE Healthcare notified consignees on about 09/08/2023 via letter. Consignees were instructed that until the software update is available the device can still be utilized through an updated browser setting or through discontinuing the use of bi-directional reporting. A GE Healthcare representative will contact each consignee to arrange for the correction. Consignees were instructed to complete and return the provided acknowledgement response.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026