| Class 2 Device Recall CyberKnife M6 | |
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 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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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/ Manufacturer |
Accuray Incorporated 1240 Deming Way Madison WI 53717-1954
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For Additional Information Contact | Accuray Customer Support 877-668-8667 |
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 | Other |
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 |
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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.
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