| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00436-2 |
| Product Name/Description |
DigitalDiagnost (Digital X-ray System)
ARTG number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
The footboard of the Patient support for stitching can be fixed in upper position. When the fix clamp (hook) is not correctly adjusted into its correct position, the footboard is not securely held. If it falls down, it may hurt the operator's or patient's foot (e.g. when moving the stand or when the operator fails to fix it correctly upon moving the board up). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising their customers to ensure that the hook is securely holding the footplate when in a vertical position. A redesigned hook is under development and will be fitted when complete. This action has been closed-out on 18/02/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |