| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00340-1 |
| Product Name/Description |
Brilliance CT and Ingenuity CT with software versions v4.13 and v4.1.4 (Computed tomography full-body x-ray system)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
23/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
On the affected CT systems and software versions, the issue relates to the auto transfer to the Remote devices (such as PACS), where there is a possibility for intermittent failures to send all images/data series automatically. The images remain on the local storage device until manually transferred to the remote device. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users of affected CT systems to assure that all images are transferred by checking that images are available on any remote devices before images/data series are deleted from local storage device. If there are missing images/data series on remote devices, the user can manually transfer images/data series to remote devices. Philips will be completing a software upgrade as a permanent fix. This action has been closed-out on 23/06/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |