| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00848-1 |
| Product Name/Description |
DigitalDiagnost Release 3.1.x
ARTG Number: 117662 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/07/2017 |
| 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 is requesting that users:
-Read the supplied notice.
-Distribute the supplied notice to all users of the device in your facility.
-Complete the response form and return it to Philips via fax/email within 3 business days as per the instructions in the customer letter.
Philips plans to install a software upgrade in affected systems, which will eliminate this issue. A Philips Service Engineer will contact users when the Field Action Kit is available to be implemented.
Should users need to communicate with Philips with regard to this matter, reference Field Change Order 71200170.
This action has been closed out on the 16/11/2018. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |