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U.S. Department of Health and Human Services

Class 2 Device Recall Cyberknife Robotic Radiosurgery System

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  Class 2 Device Recall Cyberknife Robotic Radiosurgery System see related information
Date Initiated by Firm May 01, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on November 30, 2010
Recall Number Z-1862-2008
Recall Event ID 48164
510(K)Number K072504  
Product Classification Medical charged-particle radiation therapy system - Product Code IYE
Product Accuracy Cyberknife Robotic Radiosurgery System, medical charged particle radiation therapy device. Model number 020700 (axum/standard treatment couch) and 021756 hand controller. The device 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.
Code Information All models.
Recalling Firm/
Manufacturer		 Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact
408-716-4600
Manufacturer Reason
for Recall		 Couch may move unexpectedly, which may result in patient impacting the linear accelerator.
FDA Determined
Cause 2		 Software design
Action All affected sites were notified via customer advisory notice. The Standard Treatment couch firmware will be updated and all affected sites will be retrofitted. Contact Customer Service at 1-877-668-8667 (USA) or 1-408-716-4700 (non-USA) or customersupport@accuray.com for additional information.
Quantity in Commerce 105 units
Distribution Product was distributed throughout the US and to China, Taiwan, Korea, Italy, Malaysia, Germany, Netherlands, Vietnam, Greece, Spain, and Puerto Rico.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = ACCURAY INCORPORATED
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