Medical device manufacturer, Accuray, has issued a medical device safety alert concerning its CyberKnife Treatment Delivery System.
The manufacturer has discovered an issue related to specific batches of calibration film used with the Ball-Cube II phantom in calibrating the CyberKnife Treatment Delivery System (CyberKnife System). The Ball-Cube II phantom calibration film (Ball-Cube II film) was not manufactured within necessary dimensions and may introduce up to 0.5mm of positional inaccuracy to the CyberKnife System. This inaccuracy is within the 0.95mm specification for overall delivery accuracy of the CyberKnife System. However, it is an additional source of error that when added to other sources of error may exceed the expected positional tolerance of the system.
According to the manufacturer, only the Ball-Cube II film manufactured from 1 August 2017 to 31 July 2018 and labeled with "Ashland" are affected. Most systems calibrated using the affected Bait-Cube II film will still operate within the 0.95mm overall delivery accuracy. A small portion of systems may have up to a 1.45mm error in positional accuracy.
The affected users are recommended to take the following actions to ensure CyberKnife System positional accuracy is within specifications:
Product removal and replacement are on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 28 August 2018