| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01024-1 |
| Product Name/Description |
Mobile Detector Holder for DigitalDiagnost System (Digital diagnostic x-ray System). Models: Single Detector, Dual Detector, Release 3
System codes: 712020, 712022 & 712025
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
10/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The Wireless Portable Detector is fixed in the Mobile Detector Holder via a lock mechanism. The 4 countersunk screws, that are used to attach the lock, mechanism, can become loose. If this happens and the mechanism fails, the detector may fall down when the holder is rotated 90 degrees clockwise. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The user should control the lock mechanism of the Mobile Detector Holder. In case the lock mechanism can be moved without pressing the actuator, the holder should not be rotated Clockwise. Philips Healthcare will secure the 4 countersunk screws, which are used to attach the lock mechanism, with thread locker (e.g. LOCTITE 243). |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |