| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01595-1 |
| Product Name/Description |
Philips Ingenia 1.5T and Ingenia 3.0T MR systems with Ingenia MR-OR solution
ARTG Number: 230064 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
12/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
There is an electrical component called MR-OR Laser control board in the FlexTrak OR trolley, under the Interface Adapter. In production, two MR-OR Laser control boards have been found where the Laser control board has been assembled incorrectly, leading to insufficient isolation distance. Hence, there is a possibility that a patient or user may be exposed to a very small, level of touch current. In practice, the current is so low that it may not even be noticed. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips has revised the design of the control board and is sending out service engineers to install the revised boards.
This action has been closed-out on 23/03/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |