Recall Z-0036-2012 ยท IYE Accelerator, Linear, Medical
Accuray Incorporated
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
| Date | Oct 11, 2011 (initiated Sep 12, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 Suppor |
| Quantity | 236 total devices |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102650 | CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM Accuray Incorporated, Nov 17, 2010 |