SUNNYVALE, Calif., April 18, 2013 – Accuray Incorporated (Nasdaq: ARAY) announced today clarification on two voluntary recalls that the company initiated on March 19, 2013.
In keeping with its commitment to patient safety and total quality management, 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 SeriesTM 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 gear box 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.
“The recent FDA recall announcement comes roughly a month after Accuray took the necessary steps to voluntarily recall affected components. We are pleased to report that no known injuries have been reported to date as a result of these issues, and that we took the voluntary action to ensure that our product quality and outstanding safety record are maintained,” said Joy Sacmar, vice president of regulatory affairs and quality assurance of Accuray. “Events such as these are not uncommon in our industry.”
Accuray Incorporated (Nasdaq: ARAY), is a radiation oncology company that develops, manufactures and sells personalized, innovative treatment solutions that set the standard of care with the aim of helping patients live longer, better lives. The Company’s leading-edge technologies deliver the full range of radiation therapy and radiosurgery treatments. For more information, please visit www.accuray.com.
Safe Harbor Statement
Statements made in this press release that are not statements of historical fact are forward-looking statements and are subject to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release relate, but are not limited, voluntary recalls, corrective actions, and safety record. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations, including risks detailed from time to time under the heading “Risk Factors” in the company’s report on Form 10-K filed on September 10, 2012, as updated in our Form 10-Qs filed on November 8, 2012 & February 6, 2013, and as updated periodically by our other filings. Forward-looking statements speak only as of the date the statements are made and are based on information available to the Company at the time those statements are made and/or management’s good faith belief as of that time with respect to future events. The Company assumes no obligation to update forward-looking statements to reflect actual performance or results, changes in assumptions or changes in other factors affecting forward-looking information, except to the extent required by applicable securities laws. Accordingly, investors should not place undue reliance on any forward-looking statements.