Medical device manufacturer, Accuray, has issued a medical device safety alert concerning its CyberKnife M6 Treatment Delivery System Robot Wrist Inspection.
The manufacturer has been informed of two issues related to components of the robot contained within the CyberKnife M6 System. The issues involve the wrist assembly which is the final linkage between the robot arm and the linear accelerator. One issue relates to the fastening process for the wrist assembly which may not have been implemented properly for specific units. The second involves incorrect material being used in a small number of wrist castings.
According to the manufacturer, only Accuray CyberKnife M6 Systems may potentially be affected by these issues. These issues may lead to premature wrist failure, resulting in a linear accelerator fall.
The manufacturer will inspect all CyberKnife M6 Systems to identify whether each system contains the fastening process variation or the affected wrist components. If the manufacturer detects either issue, it will arrange for the remediation of the specific system. No correction is necessary for systems that are inspected and found not to contain the fastening process variation or the wrist casting with incorrect material.
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 16 Oct 2018