| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00031-1 |
| Product Name/Description |
Brilliance CT 16 Air, 64, Big Bore, iCT, iCT SP, Ingenuity CT, Ingenuity Core, Ingenuity Core128 and Ingenuity Flex
ARTG number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
14/01/2015 |
| Responsible Entity |
|
| Reason/Issue |
A potential problem with the vertical motor / brake assembly on a manufacturing lot of the patient support / couch was discovered, which may result in uncommanded vertical patient support / couch motion. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised that when preparing and operating the device end users are advised to take extra caution while the patient is near the patient support. If any un-commanded motion is experienced end users are requested to discontinue use of the device and to contact their local service provider.
A Philips Field Service Engineer will service your system to resolve the issue. This action has been closed-out on 15/07/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |