| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01434-1 |
| Product Name/Description |
IntelePACS with software versions 4-3-1 and up
Software versions:
PACS 4-3-1 R49, PACS 4-3-2 R11, PACS 4-3-4 R39, PACS 4-6-1 R107, PACS 4-8-1 R65, PACS 4-9-1 R33, PACS 4-10-1 R61, PACS 4-11-1 R58, PACS 4-12-1 R45, PACS 4-14-1 R24, PACS 4-15-1 R7
ARTG Number: 149923
(Emergo Asia Pacific Pty Ltd T/a Emergo Australia Pty Ltd - Picture archiving and communication system, radiology) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Intelerad Medical Systems received a complaint from a client notifying a problem that could occur on the IntelePACS software.
The issue is triggered when plain text reports from external sources have been modified to be HTML compatible, and by the presence of the less than (<) character in the report. When viewing a report, the less than character is not present while it was there in the original report received by IntelePACS. In other cases, when the character is present in a combination with other characters, parts of the report text following the less than character are not displayed depending on the Intelerad application used by the end-user to review the reports.
There is a possibility that incomplete information is presented to the radiologist or referring physician. The absence of the information in the report could affect the decision made in relation with the patient care. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is advising users who utilise reports with HTML from external sources, that the affected issue may occur depending on the HTML formatting provided by the external source. If users are affected, a review of configurations of the external source is recommended.
Intelerad is advising users that a configuration change and software upgrade will be implemented as a permanent correction.
This action has been closed out on 11/02/2019 |
| Contact Information |
03 9036 2436 - Intelerad Oceania |