Navigation Links
Accuray Provides Clarification on Recently Initiated Voluntary Recalls
Date:4/18/2013

SUNNYVALE, Calif., April 18, 2013 /PRNewswire/ -- 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 Series™ 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."

About Accuray
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.

 


'/>"/>
SOURCE Accuray Incorporated
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Accuray Launches First Study to Compare CyberKnife® SBRT to Surgery and IMRT for Treatment of Early-Stage Prostate Cancer
2. Accuray Announces Results for Third Quarter Fiscal 2012
3. Accuray Appoints Richard Pettingill, LFACHE to Board of Directors
4. Accuray and the German Cancer Research Center Sign Master Research and Collaboration Agreement
5. Accuray Incorporated to Speak at Jefferies Global Healthcare Conference
6. Accuray Incorporated to Speak at Wells Fargo Healthcare Conference
7. Accuray Rolls Out Comprehensive Customer Service Program in Japan
8. One Year After TomoTherapy Acquisition, Accuray on Track to Meet or Exceed Integration Success Metrics And Expecting Near-term Return to Profitability
9. Accuray and Erasmus Medical Center Sign Master Research and Collaboration Agreement
10. Accuray to Acquire Morphormics, Inc.
11. Accuray Incorporateds CEO to Speak at Morgan Stanley Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... Calif. , June 24, 2016  American Respiratory Labs (ARL), ... is now able to perform sophisticated lung assessments in patients, homes, ... , Inc. Patients are no longer limited to ... EasyOne PRO ® , ARL patients like Jeanne R. of ... in the comfort of her own home. ...
(Date:6/24/2016)... Belgium , June 24, 2016 ... the appointment of Dr. Edward Futcher ... Non-Executive Director, effective June 23, 2016.Dr. Futcher was ... Nominations and Governance Committees.  As a non-executive member ... independent expertise and strategic counsel to VolitionRx in ...
(Date:6/23/2016)... BEVERLY HILLS, Calif. , June 23, 2016 ... faced the many challenges of the current process. Many of ... option because of the technical difficulties and high laboratory costs ... would have to offer it at such a high cost ... to afford it. Dr. Parsa Zadeh , ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... ... PawPaws brand pet supplements owned by Whole Health Supply is ... of felines. The formula is all-natural and is made from Chinese herbs that have ... Kidney Support Supplement Soft Chews are Astragalus Root Extract and Rehmannia Root Extract ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX users ... - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 ... Pro X . Simply select a ProHand generator and drag it above media or ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin Johnson ... Recently, he has implemented orthobiologic procedures as a method for treating his patients. ... the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic surgeons ...
(Date:6/24/2016)... ... June 24, 2016 , ... A recent article ... are unfamiliar with. The article goes on to state that individuals are now more ... these less common operations such as calf and cheek reduction. The Los Angeles area ...
Breaking Medicine News(10 mins):