CyberKnife Robotic Radiosurgery System, medical charged-particle radiation therapy system, manufactured by Accuray Inc., Sunnyvale, CA. Indicated for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall Z-0714-2011 · Posted 2010-12-16
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Recalling FirmAccuray Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-10-28
Date Terminated2011-04-01
Product Quantity219 units
Reason for Recall
If users modify the dose calculation box to cover just the contoured anatomy and not the entire CT volume, dosage may not be properly calculated.
Firm Action
Accuray Inc., sent an "URGENT DEVICE CORRECTION" letter dated October 21, 2010, to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to increase the size of the dose box to include CT volume, not just the contoured anatomy; recalculate dose at high resolution, and examine the treatment plan to ensure that applicable organs at risk are accounted for and all portions of the patient receive the desired level of doses.
If you have any questions or concerns regarding this issue, please do not hesitate to contact Accuray Customer Support at +1-877-668-8667 (USA), +1-408-716-4700 (non-USA) or email: [email protected].
Root Cause
Other
Distribution Pattern
USA and countries of: Athens, Belgium, Canada, China, Czech Republic, France, Germany, India, Italy, Japan, Korea, Malaysia, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Thailand, The Netherland, Turkey, Ukraine, United Kingdom, Vietnam, Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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