| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00763-1 |
| Product Name/Description |
DIRECTVIEW Software versions 5.6 & greater and 5.7 with DR LLI Auto Stitch option on DRX Evolution with Premium and Full Featured Wall Stands
(Digital X-ray system)
ARTG number: 136112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
21/08/2015 |
| Responsible Entity |
|
| Reason/Issue |
Carestream Health has identified a software issue that impacts image alignment when using the automatic stitching option for long length images. If there is no use of external fiducial markers or measurement tools (eg. radiopaque ruler) when building a composite image and the technologist relies solely on the auto stitching software, there is a risk of undetected stitching errors. This may lead to potential diagnosis errors if measurements taken from just that image were
relied on. Any injury resulting from this could lead to delays in treatment or the need for further diagnostic imaging techniques. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Whilst there have not been any diagnosis errors reported, Carestream Health is conducting this action to update the software on affected devices to correct this issue. In the interim, Carestream Health recommends that the auto-stitching feature is turned off and the manual stitch editor used to create all composite images until the software update has been made to affected devices. This action has been closed-out on 12/08/2016. |
| Contact Information |
02 9919 4562 - Carestream Health |