FDA Medical Device Recalls (openFDA)
Accuray Incorporated: 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.
- Recall number
- Z-0408-2019
- 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.
- Status
- Terminated
- Initiated
- 2018-09-26
- Posted
- not on file
- Terminated
- 2021-05-12
- Reason
- 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
- 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: FocusCenter@Kuka.com.
- Quantity
- 93 units
- Distribution
- worldwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K150873"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 3003873069
- Firm city
- Madison
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28