Class 2 Device Recall CyberKnife Treatment Delivery System

• Date Initiated by Firm: December 23, 2024
• Date Posted: January 27, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1023-2025
• Recall Event ID: 95814
• 510(K)Number: K170788
• Product Classification: Accelerator, linear, medical - Product Code IYE
• Product: CyberKnife Treatment Delivery System, REF 0660000 The CyberKnife System may be labeled as CyberKnife M6TM or VSI TM Robotic Surgery System. The CyberKnife Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
• Code Information: This issue affects all CyberKnife Treatment Delivery Systems using the STC. UDI-DI Pending. Unit numbers: C0014 C0042 C0047 C0056 C0059 C0064 C0066 C0071 C0074 C0076 C0077 C0085 C0086 C0089 C0091 C0092 C0093 C0099 C0100 C0101 C0115 C0117 C0119 C0131 C0137 C0140 C0162 C0166 C0168 C0172 C0173 C0174 C0177 C0181 C0182 C0186 C0197 C0200 C0205 C0234 C0236 C0239 C0240 C0241 C0246 C0254 C0258 C0259 C0263 C0266 C0268 C0270 C0271 C0274 C0277 C0280 C0282 C0286 C0289 C0291 C0292 C0293 C0297 C0298 C0299 C0300 C0301 C0302 C0303 C0304 C0305 C0306 C0309 C0310 C0312 C0313 C0317 C0319 C0321 C0325 C0328 C0331 C0339 C0343 C0345 C0351 C0352 C0353 C0355 C0356 C0357 C0360 C0363 C0365 C0368 C0369 C0370 C0373 C0377 C0380 C0381 C0382 C0383 C0384 C0386 C0388 C0390 C0394 C0396 C0397 C0399 C0401 C0402 C0403 C0405 C0411 C0413 C0416 C0417 C0420 C0423 C0424 C0429 C0430 C0432 C0435 C0436 C0438 C0440 C0441 C0444 C0446 C0447 C0451 C0457 C0458 C0460 C0464 C0467 C0470 C0473 C0476 C0479 C0480 C0482 C0484 C0485 C0487 C0493 C0494 C0496 C0500 C0501 C0502 C0504 C0515 C0516 C0517 C0519 C0520 C0521 C0524 C0526 C0527 C0528 C0529 C0530 C0531 C0532 C0533 C0534 C0535 C0536 C0537 C0539 C0542 C0544 C0545 C0546 C0547 C0548 C0550 C0552 C0553 C0554 C0555 C0556 C0557 C0558 C0559 C0560 C0563 C0565 C0566 C0569 C0570 C0572 C0573 C0575 C0576 C0578 C0580 C0584 C0585 C0586 C0592 C0594 C0599 C0602 C0607 C0608 C0612
• Recalling Firm/ Manufacturer: Accuray Incorporated; 1240 Deming Way; Madison WI 53717-1954
• For Additional Information Contact: 608-824-2800
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Component design/selection
• Action: On December 23, 2024, the firm began notifying customers via Urgent Field Safety Notice letters. Customers were informed that they may continue to use the CyberKnife System clinically, but were reminded to ensure patients are attended when positioning, re-positioning, and leaving the STC. Starting in December, Accuray Customer support will contact customers to schedule service to provide a full inspection and to replace the existing snap rings on the affected retention mechanism of the STC.
• Quantity in Commerce: 212
• Distribution: Worldwide - US Nationwide 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = IYE