—#203342

Product

Universal Viewer Workflow Manager, Image processing radiological system

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K211312
Affected 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.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare
Address: 500 W Monroe St, Chicago, Illinois 60661-3671

Distribution

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.

Timeline

Recall initiated: 2023-09-08
Posted by FDA: 2023-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203342. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.