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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 Philips Electronics Australia Ltd
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.
Contact Information 1800 251 400 - Philips Customer Care Centre