CLASS II Device recall · Reported 3 Jan 2018 · FDA Enforcement Report

TomoHDA(R) System recalled by Accuray Incorporated

Accuray is recalling TomoHDA(R) System. The recall was initiated on 17 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 110033 110137 110155 110206 110221 110290 110318 110348 110353 110360 110364 110384 110408 110410 110411 110452 110457 110463 110473 110475 110476 110477 110478 110479 110481 110483 110484 110485 110486 110487 110488 110489 110490 110492 110493 110496 110498 110500 110502 110513 110514 110515 110516 110518 110520 110521 110523 110524 110526 110529 110530 110535 110538 110542 110543 110550 110551 110557 110559 110560 110561 110564 110567 110571 110572 110575 110580 110582 110583 110584 110585 110586 110587 110588 110593 110598 110599 110600 110603 110604 110605 110609 110610 110612 110613 110614 110616

Quantity recalled87 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0289-2018
FDA event ID: 78686
Recalling firm: Accuray, Madison, WI
Classification: Class II
Status: Terminated
Recall initiated: 17 Nov 2017
FDA classified: 26 Dec 2017
Reported: 3 Jan 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

17 Nov 2017	Recall initiated by company
26 Dec 2017	Classified by FDA	+39 days
3 Jan 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Uncontrolled couch Z-axis movement (descent)

Product as listed by the FDA

TomoHDA(R) System, Model Number 1018286 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.

Where it was distributed

Worldwide Distribution

Questions about this recall

Why was it recalled?

Uncontrolled couch Z-axis movement (descent)

Which lots are affected?

Serial Numbers: 110033 110137 110155 110206 110221 110290 110318 110348 110353 110360 110364 110384 110408 110410 110411 110452 110457 110463 110473 110475 110476 110477 110478 110479 110481 110483 110484 110485 110486 110487 110488 110489 110490 110492 110493 110496 110498 110500 110502 110513 110514 110515 110516 110518 110520 110521 110523 110524 110526 110529 110530 110535 110538 110542 110543 110550 110551 110557 110559 110560 110561 110564 110567 110571 110572 110575 110580 110582 110583 110584 110585 110586 110587 110588 110593 110598 110599 110600 110603 110604 110605 110609 110610 110612 110613 110614 110616

Where was it sold?

Worldwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 78686

Reported	Class	Recall	Company	Reason	Where
3 Jan 2018	CLASS II	TomoH(R) System recalled by Accuray Incorporated	Accuray	Other	WI
3 Jan 2018	CLASS II	TomoHD(R) System recalled by Accuray Incorporated	Accuray	Other	WI
3 Jan 2018	CLASS II	Hi-Art(R) System recalled by Accuray Incorporated	Accuray	Other	WI

More recalls from Accuray

All 22

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
8 Jul 2026Device	CLASS II	Cyberknife Treatment Deliver System equipped recalled	Accuray	Device Malfunction	Nationwide
5 Feb 2025Device	CLASS II	CyberKnife Treatment Delivery System recalled by Accuray Incorporated	Accuray	Other	Nationwide
6 Sep 2023Device	CLASS II	Upper roller bracket recalled by Accuray Incorporated	Accuray	Device Malfunction	Nationwide
24 Mar 2021Device	CLASS II	CyberKnife Treatment Delivery System recalled by Accuray Incorporated	Accuray	Other	Nationwide

Other Imaging Equipment recalls

All 2,347

Reported	Class	Recall	Company	Reason	Where
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Computed Tomography X-ray System recalled by Shanghai United Imaging	Shanghai United Imaging Healthcare	Device Malfunction	Nationwide