Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
FDA Recall Z-0828-2014 · Posted 2014-01-27
Advertisement
Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-01-13
Date Terminated2014-11-25
Product Quantity302 devices; 149 in US, 153 out of US.
Reason for Recall
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
Firm Action
Urgent Medical Device Correction notification letter were sent out beginning January 14, 2014 by trackable method. Letters describe potential problem and provide inspection instructions to be performed prior to use.
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Colombia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam
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