| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00860-1 |
| Product Name/Description |
Merge iConnect Enterprise Archive (iCEA) with software versions 8.80 through 9.4.4 (a picture archiving and communications system)
ARTG Number: 206683 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/06/2016 |
| Responsible Entity |
|
| Reason/Issue |
This recall has been initiated because of an error when viewing prior results. A pixel offset issue can occur when prefetching a prior image from the LTA to a local cache resulting in the viewer being unable to display it. The original study on the LTA is unaffected.
In iCEA version 8.80, the pixel offset algorithm for images changed from absolute to relative offset. In normal operation, the new offset algorithm presents no risk. However, a pixel offset issue can occur when running a heterogeneous mix of iCEA versions spanning the LTA and FIC. More specifically, the issue can occur when running a pre-8.80 version of the LTA with an 8.80 or later version for the FIC. If prior studies are not available for viewing, this may lead to delay in treatment for the patient, however there are no reports of injuries as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Merge has a released software fix available for this issue. In the interim, Emergo is advising users of the following workaround. Do not run a mix of pre-8.80 software for LTA and an 8.80 version or later for the FIC. When prefetching, send uncompressed studies from the LTA to the FIC. Restore images manually from LTA using the webadmin tool. This action has been closed-out on 22/02/2017. |
| Contact Information |
02 9006 1662 – Emergo Australia |