Medical device manufacturer, Accuray, has issued a medical device safety alert concerning its CyberKnife System with Standard Treatment Couch.
The manufacturer has discovered an issue related to the Standard Treatment Couch (STC). Following treatment, a patient was sitting on the STC with a clinical staff member at their side. When the patient stood up, the couch tilted and moved freely in the roll direction. The patient fell to the floor however, there was no injury to the individual and no further medical attention was necessary. The couch was able to move due to a loose linkage arm that connects to the roll motor in the STC.
According to the manufacturer, while unlikely, the set screws that connect the linkage arm to the roll motor can loosen over time. The motion of a patient standing up can unseat the linkage arm. The immediate resolution at the clinical site was to reassemble the linkage and tighten the set screws.
The manufacturer has a service work instruction that includes inspection of the set screws referenced above. Field Service Engineers will perform the work instruction and verify the integrity of the overall couch system, including the linkage arm and its connection to the roll motor.
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 action.
Posted on 3 March 2021