| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01217-1 |
| Product Name/Description |
Mobile Detector Holder Trolley (9890-010-88152)
(used to support the transport and utilisation of a portable/mobile radiological imaging system)
ARTG Number: 293924 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
27/09/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips has recently performed evaluations of the Mobile Detector Holder and has identified a potential issue that may affect the performance of the equipment under certain conditions. If the lock mechanism of the movable clamp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.
The Wireless Portable Detector (WPD) 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° clockwise from landscape. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
1. Users should read the notice and check the lock mechanism of the Mobile Detector Holder. The lock mechanism can be moved without pressing the actuator, the holder should not be rotated clockwise.
a. Distribute the notice to all users of the device and complete the supplied response form and return it to. Philips via fax/email within three (3) business days.
b. Philips will contact users to schedule a correction to the affected units.
This action has been closed out on 17/10/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |