CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
This recall has been terminated (originally issued October 11, 2011).
- Company
- Accuray Incorporated
- Recall Initiated
- September 12, 2011
- Posted
- October 11, 2011
- Terminated
- February 27, 2012
- Recall Number
- Z-0036-2012
- Quantity
- 236 total devices
- Firm Location
- Sunnyvale, CA
- Official Source
- View on FDA website ↗
Reason for Recall
A report and investigation determined that the set screws, which were part of the retrofit of a previous recall were incorrectly engaged at one facility which allowed rotation and subsequent descent of the assembly.
Distribution
Worldwide Distribution
Lot / Code Info
Model numbers 026430 and 028186. All units
Root Cause
Process control
Action Taken
Urgent Device Correction Letters were sent to all sites affected by the retrofit on September 12, 2011 via Fed Ex. The letter identified the affected product and the description of the potential problem. Customers were asked to inspect their Synchrony System by following the instructions provided. If the lower extension feels loose, customers should contact Accuray Customer Support immediately to schedule service of the system. The letter also states that all affected systems will be inspected and corrected, if necessary by Accuray to prevent the potential problem. Accuray Customer Support will contact customers to schedule the inspection. Questions or concerns regarding the issue should be directed to Accuray Customer Support at 1-877-8667 for US customers and 1-408-716-4700 for customers outside of the US, or customersupport@accuray.com.