| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01037-1 |
| Product Name/Description |
DigitalDiagnost (Digital Diagnostic X-ray System)
Serial Number range: 00 000 00 to 09 000 543
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
11/10/2012 |
| Responsible Entity |
|
| Reason/Issue |
The footplate of the patient carriage can be fixed in a vertical position with a hook. The hook may fail when moving the carriage, or when the operator does not secure it correctly upon moving the plate up, and the footplate can fall down. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips Healthcare is providing work around instructions and will be replacing the hook with a new design to permanently correct the issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |