CyberKnife Treatment Delivery System
Medical device recall Z-1023-2025. Published in FDA’s Enforcement Report on Feb 5, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 5, 2025. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Completed its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 212 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
212, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,377 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Completed, in FDA’s file.
“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”
openFDA, on “Completed”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 23, 2024.
- FDA classified it on Jan 27, 2025.
- FDA’s Enforcement Report published it on Feb 5, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Accuray Incorporated, of Madison, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.