| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00662-1 |
| Product Name/Description |
INTELEPACS Version 3.8.1 and up (Radiology picture archiving and communication system)
ARTG Number: 149923 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/06/2014 |
| Responsible Entity |
|
| Reason/Issue |
Intelerad Medical Systems Inc. following internal testing, is providing additional information regarding the proper usage of the IntelePACS software. This issue relates to the compression of images into JPEG 2000 (2C) format. In specific circumstances, when writing image data to storage that has filled up, the image data may become truncated. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In order to correct this issue, a new software release will be installed on affected systems. Intelerad will run an audit on the entire PACS to identify all image data that may be truncated. For any affected studies, Intelerad will be able to restore a full fidelity image if required by the customers. This action has been closed-out on 29/01/2016. |
| Contact Information |
02 9006 1662 - Emergo Australia |