| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-01277-1 |
| Product Name/Description |
MobileDiagnost wDR (digital diagnostic X-ray imaging system)
All MobileDiagnost wDR except US
ARTG number: 187112 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/12/2012 |
| Responsible Entity |
|
| Reason/Issue |
When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position on the resulting image. Electronic patient side (left / right) markers on wrong image. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
As an interim measure, Philips is advising users to manually rotate an image with the rotation tool and to use a L/R lead marker to mark the patient side permanently in the image instead of using the automatic L/R markers from the EPX-database. Philips will implement a software update to solve this issue. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |