Z-0408-2019Class II

CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and...

Name: Z-0408-2019 CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and...
Creator: Accuray Incorporated
Published: 2018-09-26
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2018-09-26 / Terminated / root cause: manufacturing process

FDA source

Accuray Incorporated began a recall of CyberKnife M6, Part Number 054000-004 The CyberKnife M6 Systems are indicated for treatment planning and image guided stereotactic radiosurgery and precision... on 2018-09-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0408-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-26
Posted: 2018-11-08
Terminated: 2021-05-12
Recalling firm: Accuray Incorporated
Product: 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.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, KUKA, issued a Field Safety Notice dated 9/13/2018 and disseminated it beginning on 09/26/2018 by mail, email, and hand delivery. The Field Safety Notice explained the issues and stated that all units would be inspected. Should a unit be faulty, the firm will arrange for remediation. If you have any technical questions, please feel free to get in touch with KUKA Account Manager or contact our hotline via phone 1-800-459-6691 or email: [email protected].
Quantity in commerce: 93 units
Distribution: worldwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0408-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0408-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-08

Product code IYE

K150873Class IICyberKnife M6 FI Sytem, CyberKnife M6 FM System, CyberKnife M6 FIM SystemAccuray Incorporated / cleared 2015-07-01

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)