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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife M6

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  Class 2 Device Recall CyberKnife M6 see related information
Date Initiated by Firm September 26, 2018
Create Date November 08, 2018
Recall Status1 Terminated 3 on May 12, 2021
Recall Number Z-0408-2019
Recall Event ID 81352
510(K)Number K150873  
Product Classification Accelerator, linear, medical - Product Code IYE
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.
Code Information 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 
Recalling Firm/
Manufacturer		 Accuray Incorporated
1240 Deming Way
Madison WI 53717-1954
For Additional Information Contact Darl Moreland
608-824-2800
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 93 units
Distribution worldwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = ACCURAY INCORPORATED
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