| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00890-1 |
| Product Name/Description |
Brilliance 6, 10, 16, 40, 64 and Brilliance CT Big Bore Systems with a Multifunction Footswitch (Full body CT diagnostic system)
ARTG Number: 98868 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/09/2012 |
| Responsible Entity |
|
| Reason/Issue |
The patient support may move in an unintended manner if the foot switch cover impinges on the foot switch. Damage to the foot switch cover can occur when the couch is lowered and the patient support cover presses down on the foot switch cover and bends it. This can lead to the foot switch cover being deformed in a manner that causes the foot switch cover to engage the UNLOAD foot switch. This can lead to unintended movement of the patient support, such as intermittent operation of up and down movement or continued movement when the pedal is released. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is providing work around instructions and is planning to replace the sheet metal multi function footswitch. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |