Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00871-1 |
Product Name/Description |
Merge PACS with software versions 6.6.1, 6.6.1.1, 6.6.2, 6.6.2.1, 6.6.2.2, 7.0, 7.0.1 (picture archiving and communication system)
Distributed from May 2014
ARTG Number: 191068 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class II |
Recall Action Commencement Date |
29/06/2016 |
Responsible Entity |
|
Reason/Issue |
This recall has been initiated because studies that have QC, PDE or HL7 ADT updates applied may fail to propagate via telmed protocol to the destination server and may fail to import on the destination server. Use of this product may result in demographic changes to studies not being passed downstream to other PACS servers whether in-house or used for tele-radiology transfers.
Not receiving updated demographics or image content may result in delay in diagnosis or treatment of the patient or misdiagnosis as the physician may not receive the required study. There have been no reports of injuries as a result of this issue. |
Recall Action |
Recall for Product Correction |
Recall Action Instructions |
Emergo is advising users to use DICOM transfers rather than telmed transfers to receiving sites. If there is a valid failure, retrieve the study from archive and resend. It is recommended that logs are reviewed to ensure that all studies have been sent to receiving physicians. Emergo will be implementing a software correction as a permanent correction. This action has been closed-out on 22/02/2017. |
Contact Information |
02 9006 1662 - Emergo Australia |