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Recall Observatory FDA recall evidence

Device product

Universal Viewer Workflow Manager, Image processing radiological system

Z-0143-2024

September 08, 2023

Class II

Product summary

Firm
GE Healthcare
Event
Event 93053
Status
Ongoing
Classification
Class II
Quantity
57 units
Official record key
device-enforcement:Z-0143-2024

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: Nationwide distribution to AR, AZ, CA, CO, DE, FL, GA, IL, IN, ME, MI, MN, MO, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX. International distribution to Austria, Canada, France, Germany, Hong Kong, Israel, Italy, Philippines, Singapore, Thailand, Turkey, Vietnam.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.