CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
FDA Recall Z-0771-2016 · Posted 2016-02-09
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Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2016-01-22
Date Terminated2016-10-20
Product Quantity226
Reason for Recall
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.
Firm Action
Accuray sent an Urgent Safety Advisory Notification letters dated January 22, 2016 to all affected customers by trackable mail method. The letters identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the Acknowledgement form. For questions contact Customer Support at 1-877-668-8667 or visit the Accuray Technical Solution Center at http://www.accuray.com/services-support
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium.
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.
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