| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01022-1 |
| Product Name/Description |
Carestream PACS Client Workstation version 11.3.2.0 / 11.3.2.4 / 11.4
Catalogue number & description:
1308519 VIRT PWR Reading Basic SW Workgroup
1530633 VIRT PWR Reading Basic SW 8 Pack
1467067 Virtual Reading Basic SW Workgroup
1405794 Virtual Reading Basic SW 8 Pack
8171837 Virtual Enterprise SW Standalone
ARTG Number: 135310 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/10/2013 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health Australia has received one report from overseas where under very specific conditions, some images from multi-slice studies such as CT and MR may not load into the viewer application. An incorrect number of images loaded may potentially lead to an incomplete study report from those images in v11.3.2.X and v11.4 installations in circumstances where usage of multi-slice data is part of the workflow scenarios.This problem occurs infrequently and only when all of the following conditions are met:
1) The version installed is v11.3.2 or v11.3.2.4 or v11.4
2) The exam type is from multi-slice modalities
3) The images are requested to load into a pre-defined hanging protocol where at least one of the hanging protocol groups includes more than 100 images.
4) A timing conflict occurs between 2 processes responsible for the load of images into memory. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that the software patch will be installed by Carestream Health Australia's engineers to address the problem. Users are also informed that should a user notice the problem prior to deployment of a permanent fix, it can easily be resolved by reapplying the same display protocol. |
| Contact Information |
02 8962 4914 - Carestream Health Australia |