| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00705-1 |
| Product Name/Description |
IntelePACS software versions from 4.5.1 to 4.11.1.
Affected software version identifiers:
· Identifier contains a “P” (for example PACS 4.5.1 P123)
OR
· Identifier contains an “R” but with a number below the following:
- PACS-4-5-1-R70
- PACS-4-6-1-R80
- PACS-4-8-1-R40
- PACS-4-9-1-R30
- PACS-4-10-1-R30
- PACS-4-11-1-R20 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Due to the asynchronous nature of image ingestion processing, a failure at the early stages of the ingestion process may occur leading to images not being visible to the end user, without any indication to the user that this has occurred.
The user may not be aware that images might be missing. A misdiagnosis or a delay in diagnosis and treatment can occur if health professionals base their diagnosis on incomplete image sets. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In order to correct this problem, Intelerad is:
1- providing concerned clients with a list of affected studies and possibly recover the missing images;
2- deploying a software update that includes both a fix and a mitigation for all clients potentially affected by the problem; and
3- periodically auditing all concerned client systems to find and report to the concerned client any new occurrences of this problem until the software update is in place. |
| Contact Information |
(02) 9006 1662 - Emergo Australia |