CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation. Accuray Incorporated, Sunnyvale, CA. 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-1098-2012 · Posted 2012-02-23
Advertisement
Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2012-01-16
Date Terminated2012-09-28
Product Quantity207
Reason for Recall
An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.
Firm Action
Accuray sent an "URGENT DEVICE CORRECTION" letter dated January 16, 2012 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter provides a work around to prevent the issue from happening. Contact Accuray Customer Support at 1-877-668-8667for questions regarding this notice.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Korea, Hong Kong, China, Canada, Turkey, India, Russia, Italy, France, Belgium, Poland, Germany, Netherlands, United Kingdom, Spain, Greece, Saudi Arabia, Switzerland, Ukraine, Czech Republic, and Japan.
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.
Advertisement