Z-0288-2018Class II

TomoH(R) System, Model Number 1018284

Name: Z-0288-2018 TomoH(R) System, Model Number 1018284
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 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... 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-0288-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-17
Posted: 2017-12-26
Terminated: 2021-07-25
Recalling firm: Accuray Incorporated
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.
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: 29 units
Distribution: Worldwide Distribution
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0288-2018
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)