Recall Z-1533-2021 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
| Date | Mar 19, 2021 |
| Status | Terminated |
| Reason | When the Cross Enterprise Display option is enabled on the Centricity Universal Viewer and Workflow Manager option is used as the PACS worklist launching the viewer, the patient jacket may potentially include a different patient s comparison exam(s). |
| Root cause | Under Investigation by firm |
| Action | A Recall notification letter titled, "URGENT MEDICAL DEVICE CORRECTION" was sent to the consignees on 03/19/2021 via letter. The letter instructs the consignee that they can continue to use the device by following the below safety instructions: "1. Visually verify that the patient demographic information for all comparison exams when hung in the Image Viewer match that of the primary patient under review. 2. If you encounter comparison exams that do not belong to the primary patient under review, close the primary exam and reopen the exam from Workflow Manager." The consignee is also told to d |
| Quantity | 112 units |
| Distribution | Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182419 | Centricity Universal Viewer GE Healthcare, Dec 14, 2018 |