| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00638-1 |
| Product Name/Description |
DigitalDiagnost
Affected Products: DigitalDiagnost Release 4.0.4, 4.1.2, 4.1.3
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
13/05/2016 |
| Responsible Entity |
|
| Reason/Issue |
A firmware anomaly inside the detector (4343RC) can cause the detector to appear ready for acquisition on very short time intervals while it actual fact it is not ready, resulting in incorrectly acquired X-ray images.
If a corrupted image cannot be used for its clinical purpose, it may be necessary to retake the image, leading to additional exposure for the patient. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact the affected customers when the Field Action Kit is available to be implemented. This action has been closed-out on 16/05/2017 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |