Medical device manufacturer, Philips, has issued a medical device safety alert concerning its Allura Xper systems with software releases R7.6.x, R7.7.x, R7.8.x, ≤R8.1.17.x, ≤R8.2.17.x., UNIQ systems with software releases ≤R1.0.2 and Allura Centron with releases ≤R1.0.2.x.
The manufacturer has discovered a device software issue due to a blockage of the Microsoft Windows EventLog on the host computer for a period of up to approximately 25 seconds, with most delays between 8 and 15 seconds. According to the manufacturer, when this Windows EventLog blockage occurs, command handling (e.g. X-ray, table movement) is not possible. Furthermore, if the Windows EventLog is blocked during Xray emission, X-ray indicators on device displays may remain on after the termination of the X-ray emission for the duration of the delay. According to the manufacturer, there is no risk for unintended radiation as X-ray emission is terminated correctly when the foot pedal or hand switch is released.
Affected users should follow the action shown on the customer letter issued by the manufacturer.
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 Sep 2021