| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00034-1 |
| Product Name/Description |
MobileDiagnost wDR (mobile x-ray unit)
ARTG: 187112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/01/2013 |
| Responsible Entity |
|
| Reason/Issue |
Due to a potential electrical defect, encoder defect or software error the movement speed regulation of the MobileDiagnost wDR does not work as intended. The device may move with increasing speed and/or in the wrong direction for up to 1.5 seconds after releasing the dead man switch (handle bar). Additionally, there is the potential for batteries to overheat. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising customers to activate the emergency switch in the event of unintended movement which will immediately stop the MobileDiagnost wDR. Once a corrective action has been determined Philips will implement a fix to stop unintended movement. In addition, Philips will install a battery thermostat to the device. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |