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U.S. Department of Health and Human Services

Class 2 Device Recall TomoH(R) System

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  Class 2 Device Recall TomoH(R) System see related information
Date Initiated by Firm November 17, 2017
Create Date December 26, 2017
Recall Status1 Terminated 3 on July 25, 2021
Recall Number Z-0288-2018
Recall Event ID 78686
510(K)Number K121934  
Product Classification Accelerator, linear, medical - Product Code IYE
Product TomoH(R) System, Model Number 1018284

Product Usage:
The TomoTherapy treatment system is intended to be used as an integrated system for t he 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 tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
Code Information Serial Numbers: 110040 110083 110163 110231 110237 110289 110302 110369 110418 110461 110462 110474 110491 110494 110503 110519 110525 110533 110536 110537 110552 110554 110556 110562 110565 110570 110573 110576 110577 
Recalling Firm/
Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
For Additional Information Contact
Manufacturer Reason
for Recall
Uncontrolled couch Z-axis movement (descent)
FDA Determined
Cause 2
Software design
Action Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated the following: "Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem." For questions contact Accuray Customer Support by phoning the regional support lines.
Quantity in Commerce 29 units
Distribution Worldwide Distribution
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