| Class 2 Device Recall TomoTherapy Treatment System | |
Date Initiated by Firm | December 10, 2020 |
Create Date | January 07, 2021 |
Recall Status1 |
Terminated 3 on September 26, 2022 |
Recall Number | Z-0784-2021 |
Recall Event ID |
86993 |
510(K)Number | K121934 |
Product Classification |
Accelerator, linear, medical - Product Code IYE
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Product | TomoTherapy Treatment System - 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: H-0000-0003, 104430, 1018284. System Version 5.1.5. Serial Numbers: 110210, 110319, 110340, 110366, 110383, 110418, 110468 |
Recalling Firm/ Manufacturer |
Accuray Incorporated 1240 Deming Way Madison WI 53717-1954
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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 | 7 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 |
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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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510(K) Database | 510(K)s with Product Code = IYE
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