CLASS II Device recall · Reported 14 Nov 2018 · FDA Enforcement Report

CyberKnife M6 recalled by Accuray Incorporated

Accuray is recalling CyberKnife M6. The recall was initiated on 26 Sep 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: C0330 C0332 C0334 C0335 C0336 C0337 C0338 C0342 C0343 C0344 C0345 C0346 C0348 C0349 C0351 C0352 C0354 C0356 C0358 C0359 C0360 C0361 C0363 C0364 C0366 C0367 C0368 C0369 C0370 C0371 C0372 C0373 C0374 C0376 C0378 C0379 C0380 C0381 C0383 C0384 C0387 C0389 C0390 C0391 C0393 C0394 C0395 C0396 C0397 C0398 C0400 C0402 C0404 C0407 C0408 C0409 C0410 C0411 C0413 C0414 C0415 C0416 C0417 C0419 C0420 C0421 C0422 C0423 C0424 C0425 C0426 C0427 C0428 C0434 C0436 C0437 C0438 C0440 C0441 C0443 C0445 C0446 C0447 C0448 C0449 C0450 C0453 C0454 C0456 C0457 C0458 C0460 C0464

Quantity recalled93 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-0408-2019
FDA event ID: 81352
Recalling firm: Accuray, Madison, WI
Classification: Class II
Status: Terminated
Recall initiated: 26 Sep 2018
FDA classified: 8 Nov 2018
Reported: 14 Nov 2018
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

26 Sep 2018	Recall initiated by company
8 Nov 2018	Classified by FDA	+43 days
14 Nov 2018	Published in enforcement report	+6 days

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

Reason for recall

A robotics supplier notified Accuray of two manufacturing variations in the fastening of the in-line wrist and the casting of the wrist for the robot. The variation may result in premature failure of the component.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

Where it was distributed

worldwide distribution.

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: C0330 C0332 C0334 C0335 C0336 C0337 C0338 C0342 C0343 C0344 C0345 C0346 C0348 C0349 C0351 C0352 C0354 C0356 C0358 C0359 C0360 C0361 C0363 C0364 C0366 C0367 C0368 C0369 C0370 C0371 C0372 C0373 C0374 C0376 C0378 C0379 C0380 C0381 C0383 C0384 C0387 C0389 C0390 C0391 C0393 C0394 C0395 C0396 C0397 C0398 C0400 C0402 C0404 C0407 C0408 C0409 C0410 C0411 C0413 C0414 C0415 C0416 C0417 C0419 C0420 C0421 C0422 C0423 C0424 C0425 C0426 C0427 C0428 C0434 C0436 C0437 C0438 C0440 C0441 C0443 C0445 C0446 C0447 C0448 C0449 C0450 C0453 C0454 C0456 C0457 C0458 C0460 C0464

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.

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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

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