| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00862-1 |
| Product Name/Description |
Merge PACS with software versions V6.0.2.0 MR2 and earlier (a picture archiving and communications system)
ARTG Number: 191068 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated due to an issue in which the patient name in the Halo title bar may not update to match the name on displayed images due to the Java running out of memory. This may result in a mismatch of the displayed patient name on the Halo title bar and the displayed images. This may result in a delay in diagnosis or treatment or patient misdiagnosis. There have been no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A released software fix available for this issue. A software update has been released which adds a warning message to the user interface for the user to close some viewers whenever the Java memory usage size exceeds 97%. In the interim, Emergo is advising users to ensure the correct patient name is displayed in the Halo title bar. This action has been closed-out on 22/02/2017. |
| Contact Information |
02 9006 1662 – Emergo Australia |