| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00739-1 |
| Product Name/Description |
MobileDiagnost wDR
Model Number: 712002
ARTG Number: 187112
(Philips Electronics Australia - X-ray system, diagnostic, general-purpose, mobile, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
14/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips have identified that when the operator or a bystander touches the area of the inner part of the vertical sliding column (on which the tube arm moves up or down), without paying attention of the tube arm movement, the operator's fingers can be pinched. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips are advising that they will install a new label on affected systems. A Philips Service Engineer will contact customers when the Field Action Kit is available to be implemented.
In the interim, customers may continue to use their systems, provided they follow the Instructions for Use which outlines that users keep all body parts and clothing free of the equipment to avoid getting caught or trapped within the moving components.
This action has been closed out on 16/07/2019 |
| Contact Information |
1800 251 400 - Philips Customer Care |