| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-00767-1 |
| Product Name/Description |
Centricity Universal Viewer Zero Footprint Client Versions 6.0 SP6 through SP11.4
ARTG 246996
(GE Healthcare IITS Australia Pty Ltd - Medical image management system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/06/2022 |
| Responsible Entity |
|
| Reason/Issue |
GE Healthcare has become aware of an issue where Distance and Area measurement values can display inaccurately on images in Centricity Universal Viewer Zero Footprint Client (ZFP) that are scaled down from their original resolution.
There have been no injuries reported as a result of this issue.
|
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
GE Healthcare note that customers can continue to use their device in accordance with the User Manual and the actions highlighted under Issue 1 and Issue 2 as mentioned in the customer letter.
A GE Healthcare representative will contact them to arrange for the correction, and once the software has been corrected, the customer is asked to destroy the installation media for affected software at their site.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1-800-659-465 - GE Healthcare Service. |