Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Recall
- Recall Number
- Z-1533-2021
- Event Number
- 87652
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- LLZ
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- March 19, 2021
- Terminated
- August 11, 2023
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
Centricity Universal Viewer - Product Usage: intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
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).
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 destroy the installation media for the affected software once a GE Healthcare representative has updated the system.
Distributed nationwide to AR, CA, CO, DE, FL, IL, IN, LA, ME, NE, NJ, NV, NY, PA, SC, TX and internationally to Canada.
112 units