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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Accuray Incorporated
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0408-2019
Related Recalls
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Accuray Incorporated
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.