| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00644-1 |
| Product Name/Description |
DigitalDiagnost Release 3.1.x
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
18/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has identified a firmware anomaly inside the detector (4343RC) that can cause the detector to appear ready for acquisition at very short time intervals while it actually is not, resulting in incorrectly acquired X-ray images. A retake of the image is necessary if the captured corrupt image is clinically unusable, leading to additional exposure for the patient |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips will be installing a software upgrade in affected systems as a permanent fix to this issue. Users are advised that they will be contacted by a Service Engineer when the upgrade is available to be implemented. In the interim, users are to note if the problem occurs, they may see an underexposed image and the clinician may decide to conduct a repeat exposure. Users are advised that the system can be used according to the Instructions for Use (IFU) and to contact Philips if they have any questions.
This action has been closed out on 18/09/2018 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |