Recall Z-0143-2024 ยท LLZ System, Image Processing, Radiological
GE Healthcare
Universal Viewer Workflow Manager, Image processing radiological system
| Date | Oct 23, 2023 (initiated Sep 8, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Software design |
| Action | 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. |
| Quantity | 57 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211312 | Universal Viewer GE Healthcare, May 21, 2021 |