April 29, 2013 — Accuray has voluntarily implemented a recall of two separate components from its CyberKnife product line: the Iris Variable Aperture Collimator and the RoboCouch Patient Positioning System. The affected parts are manufactured by third-party suppliers and are being removed from the system because they failed to meet the company's specifications and standards for quality. The company has notified impacted customers, and field service personnel have been deployed to apply the corrections should they be necessary. These recalls exclude the CyberKnife M6 Series.
The first recall affects 176 units of the Iris Variable Aperture Collimator used in the CyberKnife system. Specifically, a defect was identified that could potentially result in a shift to the central axis of the radiation beam, posing a potential clinical impact to plans created using the smallest collimators. The second recall affects 16 units of the RoboCouch Patient Positioning System used with the CyberKnife system. Specifically, the gearbox responsible for patient motions may be defective. All defective gearboxes have been replaced. For both products, all affected sites have been notified and corrective actions are being taken.
For more information: www.accuray.com