| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00404-1 |
| Product Name/Description |
IntelePACS
(Image management system)
Software versions:
4.7.1 R27 and up
4.8.1 R20 and up
4.9.1 R17 and up
4.10.1 R9 and up
4.11.1 R3 and up
ARTG number: 149923 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
15/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
Images successfully transmitted to IntelePACS may not be available for reading in all studies, and the reader could be unaware of missing images.. This failure can be detected if the client has image count verification protocols. In addition if a large number of consecutive images are missing it will cause a noticeable gap in the anatomy.
This issue can arises in two scenarios:
1. For the three clients that employ ingest servers to provide temporary store-and-forward capabilities in their architecture, in some conditions, these servers fail to forward all received images to the permanent storage servers and no record of these images persist in the main archive.
2. For the remaining client architectures that do not employ temporary ingest servers, there is still a very low probability of failure for the device to properly replicate and register images when transferring them to another server. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
For the three clients using a configuration with ingest servers as temporary storage, an immediate update process was undertaken via the Client Specific Release process (completed as of 2015-04-23) to avoid the possibility of data loss. For the remaining clients, the normal Full Release Update (FRU) will be expedited. This action has been closed-out on 5/08/2016. |
| Contact Information |
02 9006 1662 - Emergo Australia |