| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00622-1 |
| Product Name/Description |
Centricity Universal Viewer Zero Footprint Client
Versions: 6.0 SP 9.x and 10.x
GTIN: 00840682102988
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 |
5/08/2024 |
| Responsible Entity |
|
| Reason/Issue |
A problem involving Centricity Universal Viewer Zero Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not shown by default to the user is identified. This occurs when the addendum is created on the same day as the original report but at a different time, and only when launched on the following browsers.
· Internet Explorer 10 (IE10)
· Internet Explorer 11 (IE11)
· Firefox
Users continue to have access to all reports via in the Series Selector. However, since the latest addendum may not be shown by default in the ZFP Viewer, this could lead to potential misdiagnosis if a user relies only on the information in the original report and does not review the addended report. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Users can continue to use their device. Follow one of the below recommendations to ensure the latest addendum is being reviewed:
1. Use Microsoft Edge or Google Chrome browsers when launching ZFP Viewer.
OR
2. If the above browsers are not a possibility, to find the addendum / latest report, review all the reports available for the study in the Series Selector.
Navigation to the series selection can be found in the User Manual under Section 2.3.3 of The Series Selector, with subheading as “Open a report/document using series selector”.
GE HealthCare will correct all affected products at no cost. |
| Contact Information |
1800 659 465 - GE HealthCare Service |