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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife M6

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  Class 2 Device Recall CyberKnife M6 see related information
Date Initiated by Firm April 10, 2018
Create Date June 01, 2019
Recall Status1 Terminated 3 on April 01, 2021
Recall Number Z-1697-2019
Recall Event ID 82664
510(K)Number K919999  
Product Classification Accelerator, linear, medical - Product Code IYE
Product CyberKnife VSI, Part Numbers:
a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan
b) 033000-010: CyberKnife VSI Robotic Radiosurgery System
Code Information a) 032500-010: CyberKnife VSI 9.6.x Robotic Radiosurgery System for Japan Serial Numbers: C0281, C0307  b) 033000-010: CyberKnife VSI Robotic Radiosurgery System Serial Numbers: C0042, C0064, C0071, C0074, C0079, C0091, C0098, C0102, C0137, C0161, C0180, C0182, C0187, C0200, C0203, C0210, C0216, C0230, C0238, C0246, C0247, C0249, C0252, C0255, C0257, C0264, C0269, C0270, C0273, C0274, C0276, C0277, C0284, C0293, C0294, C0304, C0305, C0322, C0323, C0325, C0326  
Recalling Firm/
Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
For Additional Information Contact Accuray Customer Support
Manufacturer Reason
for Recall
There is an unintended drop of a secondary collimator housing that can occur during housing Xchange(TM) workflows. Specifically, during an automated housing Xchange, an interlock may interrupt this operation causing the collimator housing to partially attach.
FDA Determined
Cause 2
Action The firm issued a field safety notice by letter on 04/10/2019. The letter explained the issue and provided safety instructions. All impacted customers with affected systems will be contacted to arrange for a software upgrade.
Quantity in Commerce 43 units
Distribution US & Italy, United Kingdom, Switzerland, Belgium, Canada, Germany, France, Japan, Poland, Netherlands, Luxembourg, Australia, Qatar, Latvia, Portugal, India, Hungary, Turkey, United Arab Emirates, Thailand
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.