CyberKnife Robotic Radiosurgery System: Lung Optimized Treatment option. The CyberKnife treatment is indicated for the 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-0382-2012 · Posted 2012-01-11
Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-11-07
Date Terminated2012-02-27
Product Quantity30
Reason for Recall
User Facility reported an anomaly where inhale and exhale CT pairs used for treatment planning did not represent the same magnitude of respiration that was displayed during treatment delivery.
Firm Action
Accuray sent a Urgent Medical Device Correction letter dated November 7, 2011, via Federal Express to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The information provided in this letter will be incorporated in user manuals shipped with the CyberKnife system.
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 )
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution -- USA ( nationwide ) including the states of FL, TN, IL, NJ, CO, PA, MD, CA, MS, MN, SC, WA, OK, GA, AZ, and TX., and the countries of France and United Kingdom.
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.