| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00830-1 |
| Product Name/Description |
Allura Xper with FlexVision large screen monitor
System names: Allura 8.1.25.0, Allura 8.1.25.1, Allura 8.1.25.5, Allura 8.2.25.0, Allura 8.2.25.5 and Allura 8.2.27
ARTG Number: 225815
(Philips Electronics Australia Ltd - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
25/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Philips has received reports of instances where after a continuous operation of more than one and a half days, the image on the FlexVision large screen monitor froze for about 15 seconds. Thereafter, the system restored itself and was fully operational again.
This is only applicable to Allura Systems with a FlexVision large screen monitor. All other monitors to the system are not affected.
To date, Philips is not aware of any injuries that may have occurred due to this issue. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Philips is advising this issue will be resolved in a software upgrade, expected to be available by the second half 2018. Users will be contacted by Philips when the software is available for installation.
In the interim, users are advised to restart the system at least once per day to prevent occurrence of this issue.
This action has been closed out on 01/02/2021 |
| Contact Information |
1800 251 400 - Philips Customer Care Centre |