| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00812-1 |
| Product Name/Description |
Allura Xper R8.2.0 (Fluoroscopic diagnostic x-ray system)
Product codes: 722028, 722035
ARTG number: 98560 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
22/07/2014 |
| Responsible Entity |
|
| Reason/Issue |
As result of a faulty Automatic Motion Controller (AMC), a problem in the Power On Self Test (POST) error handling was detected, which can result in a hazardous movement of the C-arc. This can only occur during startup of the system. When the problem in the POST error handling during startup occurs, the C-arc might move unexpectedly. The Image Detector (which is connected to the same AMC axis motion controller) may also move unexpectedly. The issue does not occur at every startup and is only present if a POST-error handling is detected during the POST phase.
|
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising that the user must be cautious for any unexpected movement of the C-arc and Image Detector when a system start-up (cold restart) is required during a procedure to protect their own safety and the safety of the patient on the table. Philips field service engineers will install software release R8.2.0.3 which addresses the Positioning Software to respond properly to this error reported by the AMC motion controller during startup of the system. This action has been closed on 05/08/2016. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |