| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00274-1 |
| Product Name/Description |
Allura Xper with software release FD R8.1.16
(Fluoroscopic angiographic x-ray system)
ARTG Number: 175708 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Philips Healthcare has identified through customer complaints and internal testing that uncontrolled geometry movements can occur when the system is not switched on/off regularly. Due to the nature of the problem, the user will perceive a gradually increased sluggishness. Upon activation of the IU controls an uncontrolled geometry movement can occur. The uncontrolled movements are immediately stopped upon release of the IU controls. All safety measures such as current sensing, 3D model and bodyguard remain intact avoiding serious harm to patient and bystander. A system reboot will restore normal system operation. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Philips is advising users to regularly restart the system as per the Instructions for Use (IFU) once a day to avoid uncontrolled movements. A software update will be provided as a permanent fix. This action has been closed-out on 26/05/2017. |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |