Cyberknife Robotic Radiosurgery System. A radiation therapy device, MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture Collimator, Software version 3.0. Product is 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.
This recall has been terminated (originally issued January 17, 2009).
- Company
- Accuray Inc
- Recall Initiated
- November 14, 2008
- Posted
- January 17, 2009
- Terminated
- December 2, 2010
- Recall Number
- Z-0629-2009
- Quantity
- 4 units
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
System may use random incorrect data to calculate dose. Resulting dose calculation error can exceed 100% of correct dose which may lead to serious patient injury.
Distribution
Nationwide Distribution. Product was distributed to 4 medical facilities in the US.
Lot / Code Info
All units that have MP software version 3.0 and the Iris Collimator in clinical use at the same time are subject to this recall.
Root Cause
Software design
Action Taken
An Urgent Advisory Notification letter dated November 14, 2008 was issued to all sites via Fed Ex. The letter identifies the issue and required actions. The user was instructed not to modify current extrapolation depth settings and to contact Accuray Incorporated Customer Support prior to making any changes. Please direct any questions or concerns regarding this issue to Accuray Incorporated Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700 (outside of USA) or customersupport@accuray.com.