Z-0287-2018Class II

TomoHD(R) System, Model Number 1018283

Name: Z-0287-2018 TomoHD(R) System, Model Number 1018283
Creator: Accuray Incorporated
Published: 2017-11-17
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2017-11-17 / Terminated / root cause: software

FDA source

Accuray Incorporated began a recall of 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... on 2017-11-17. FDA classified it as Class II and gives the reason as "Uncontrolled couch Z-axis movement (descent)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0287-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2017-12-26
Terminated: 2021-07-25
Recalling firm: Accuray Incorporated
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.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Uncontrolled couch Z-axis movement (descent)
Root cause tag: software
FDA root cause: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0287-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0286-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26
Z-0287-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26
Z-0288-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26
Z-0289-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-03	2017-12-26

Product code IYE

K121934Class IITomotherapy Treatment SystemAccuray Incorporated / cleared 2012-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)