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U.S. Department of Health and Human Services

Class 2 Device Recall TomoHD(R) System

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  Class 2 Device Recall TomoHD(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-0287-2018
Recall Event ID 78686
510(K)Number K121934  
Product Classification Accelerator, linear, medical - Product Code IYE
Product TomoHD(R) System, Model Number 1018283

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: 110081 110100 110158 110180 110185 110194 110197 110208 110214 110228 110265 110266 110268 110286 110300 110311 110315 110332 110333 110347 110350 110354 110355 110357 110363 110368 110376 110378 110379 110380 110381 110385 110386 110387 110388 110390 110391 110392 110394 110396 110397 110401 110402 110405 110406 110407 110409 110412 110413 110414 110415 110419 110420 110422 110425 110426 110427 110430 110431 110434 110436 110437 110441 110442 110444 110445 110446 110447 110448 110451 110453 110454 110455 110458 110460 110464 110465 110466 110467 110469 110471 110472 110480 110482 110501 110504 110506 110511 110512 110517 110527 110528 110531 110532 110534 110539 110540 110541 110544 110545 110546 110547 110548 110549 110553 110555 110558 110563 110566 110569 110574 110578 110579 110591 110594 110596 110597 110606 
Recalling Firm/
Manufacturer		 Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
For Additional Information Contact
608-824-2800
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 118 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
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