Centricity Universal Viewer Workflow Manager, Image processing radiological system
This recall is currently active, issued October 23, 2023. It was issued by Ge Healthcare.
- Company
- Ge Healthcare
- Recall Initiated
- September 8, 2023
- Posted
- October 23, 2023
- Recall Number
- Z-0142-2024
- Quantity
- 85 units
- Firm Location
- Chicago, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
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.
Lot / Code Info
UDI/DI 00840682145794, 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.
Root Cause
Software design
Action Taken
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.