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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-1696-2019
Recall Event ID 82664
510(K)Number K150873  
Product Classification Accelerator, linear, medical - Product Code IYE
Product CyberKnife M6, Part Numbers:
a) 0660000: CyberKnife Treatment Delivery System
b) 053101-010: CyberKnife M6 FI Treatment Delivery System
c) 053201-010: CyberKnife M6 FM Treatment Delivery System
d) 053301-010: CyberKnife M6 FIM Treatment Delivery System
e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System
f) 053501-010: CyberKnife Matrix Tier 2 TDS
Code Information a) 0660000: CyberKnife Treatment Delivery System Serial Numbers: C0434, C0436, C0437, C0438, C0440, C0441, C0443, C0444, C0445, C0446, C0447, C0448, C0449, C0450, C0453, C0454, C0456, C0457, C0458, C0460, C0464, C0465, C0466, C0472, C0475   b) 053101-010: CyberKnife M6 FI Treatment Delivery System Serial Numbers: C0334, C0381  c) 053201-010: CyberKnife M6 FM Treatment Delivery System Serial Numbers: C0363  d) 053301-010: CyberKnife M6 FIM Treatment Delivery System Serial Numbers: C0337, C0343, C0349, C0352, C0358, C0370, C0371, C0378, C0384, C0387, C0389, C0390, C0391, C0393, C0409, C0424, C0426, C0427, C0428, C0433, C0439   e) 053401-010: CyberKnife M6 FI+ Treatment Delivery System Serial Numbers: C0330, C0332, C0342, C0344, C0345, C0348, C0359, C0360, C0364, C0367, C0372, C0394, C0398, C0400, C0402, C0404, C0415, C0419   f) 053501-010: CyberKnife Matrix Tier F TDS Serial Numbers: C0396
Recalling Firm/
Manufacturer		 Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
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 68 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.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = ACCURAY INCORPORATED
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