| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00501-1 |
| Product Name/Description |
Image Suite Software Versions 3.0 and 4.0
(Radiology picture archiving and communication system)
Image Suite Software Versions 3.0 (customers with Mini-PACS Options and Hot Fix 3004 software patch) and 4.0 (customers with Mini-PACS and DICOM Store)
ARTG number: 172338 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/04/2016 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health has identified a software issue related to image orientation. If the Image Suite software receives a Computed Tomography (CT) or Magnetic Resonance (MR) image with the Image Orientation (Patient) Tag specified, and the overlay is configured to display this tag, the Left (L) and Right (R) and Anterior (A) and Posterior (P) overlay text will be displayed opposite. That is, the left side is marked R and the right marked L and the anterior marked P and the posterior marked A. This could result in delays in a misdiagnosis or improper patient care.
There has not been any diagnosis errors reported. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Carestream Health Australia will contact the affected customers to update the software on the device to correct this issue.
In the interim, until the software update has occurred, customers who use Image Suite for CT or MR images should make users aware of the problem and take additional steps to check correct orientation of any markers. A review of past patients’ results is recommended at the discretion of the clinical director/radiologist. |
| Contact Information |
02 9919 4562 - Carestream Health Australia |