| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00762-1 |
| Product Name/Description |
MobileDiagnost wDR (digital x-ray system)
All units affected
ARTG Number: 187112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
Under the following conditions the system may execute an unintended movement and injure the operator or bystander:
- Strain gauges fail to reach the specified life time
- Operator requests movement by pressing the dead man handle switch and pushing or pulling the handle bar
- Operator/bystander standing close to the device |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to release the drive handle (dead man switch) in the event of unintended movement. Philips will be updating the strain gauges of the MobileDiagnost wDR. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |