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U.S. Department of Health and Human Services

Class 2 Device Recall TomoTherapy Treatment Delivery System with iDMS

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  Class 2 Device Recall TomoTherapy Treatment Delivery System with iDMS see related information
Date Initiated by Firm December 10, 2020
Create Date January 07, 2021
Recall Status1 Terminated 3 on September 26, 2022
Recall Number Z-0785-2021
Recall Event ID 86993
510(K)Number K171837  
Product Classification Accelerator, linear, medical - Product Code IYE
Product TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
Code Information Product Codes: 104430, 1018286, H-0000-0003, 1018283. System Version: 1.2 (also referred to as 5.6.2). Serial Numbers: 110105, 110219, 110221, 110267, 110284, 110290, 110308, 110368,  
Recalling Firm/
Manufacturer		 Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
For Additional Information Contact Daniel Biank
608-824-2971
Manufacturer Reason
for Recall		 "MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
FDA Determined
Cause 2		 Software Design Change
Action Urgent Medical Device Recall "MLC tickle error" issue during TomoHelical deliver was sent to customers beginning 12/10/2020. Accuray is planning software releases that will address this issue. All TomoTherapy systems at affected software versions will be upgraded to these versions once released.
Quantity in Commerce 8 units
Distribution Worlwide distribution - US Nationwide distribution including in the states of CA, FL, IL, ND, NJ, OK, UT and the countries of Australia, China, Italy, Switzerland, United Arab Emirates.
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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