| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00247-1 |
| Product Name/Description |
Mobile Diagnostic wDR 2.x Systems
Model Numbers: 712002, 712006
ARTG 187112
(Philips Electronics Australia Ltd - X-ray system, diagnostic, general-purpose, mobile, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
26/03/2024 |
| Responsible Entity |
|
| Reason/Issue |
Philips Mobile Diagnostic wDR 2.x Systems performance and/or imaging quality may be impacted when the SkyPlate detector is used with an accessory that has an unknown magnetic source.
The problem may occur when all three of the below conditions are met:
- The SkyPlate detector is used without an anti-scatter Grid (Grid)
- A different magnetic source is within the vicinity of the SkyPlate detector,
- The system interprets the different magnet as a Grid and automatically increases the exposure values to compensate for the false presence of a Grid.
This problem does not pose a risk to health for patients, operators, or service engineers. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are requested to
1. Follow the advice provided in the Addendum IFU (Appendix A) with their system IFU:
· A magnet in the vicinity of the small & large SkyPlate detectors can cause changes to exposure parameters. Avoid placing the indicated SkyPlate near magnets.
· Always make sure the applied exposure parameters are correct before performing an actual exposure.
2. Circulate this notice to all users of the device so that they are aware of the issue.
NB: You may continue to use your system in accordance with the intended use. |
| Contact Information |
1800 251 400 - Philips Service Delivery Team |