CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator
Medical device recall Z-0218-2015. Published in FDA’s Enforcement Report on Nov 26, 2014.
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 Nov 26, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 26 states named in where it went
- 84 devices subject to correction. 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?
Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first generation Iris Variable Aperture Collimator.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is 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.
84 devices subject to correction., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Catalog/Part number 054000-0001; Serial numbers: C0141 C0182 C0225 C0256 C0137 C0112 C0244 C0210 C0160 C0208 C0118 C0090 C0207 C0181 C0034 C0047 C0197 C0174 C0101 C0186 C0178 Serial # C0198 C0214 C0059 C0172 C0068 C0057 C0263 C0092 C0199…
Every code shown here, 603 characters
Catalog/Part number 054000-0001; Serial numbers: C0141 C0182 C0225 C0256 C0137 C0112 C0244 C0210 C0160 C0208 C0118 C0090 C0207 C0181 C0034 C0047 C0197 C0174 C0101 C0186 C0178 Serial # C0198 C0214 C0059 C0172 C0068 C0057 C0263 C0092 C0199 C0151 C0179 C0226 C0158 C0131 C0144 C0223 C0071 C0094 C0183 C0143 Serial # C0192 C0055 C0072 C0061 C0134 C0177 C0247 International Sites Serial # C0175 C0189 C0191 C0215 C0227 C0187 C0242 C0185 C0218 C0237 C0240 C0265 C0268 C0251 C0235 C0229 C0212 C0239 Serial # C0043 C0211 C0255 C0270 C0176 C0093 C0234 C0221 C0249 C0232 C0180 C0238 C0231 C0202 C0230 C0264 C0266.
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 Distribution - USA including CA, MS, FL, AZ, DC, TX, CO, CT, IL, WI, RI, NV, OK, MA, AL, NY, MO, NC, TN, PA, DE, NJ, MI, IN, KS, OH. Foreign distribution to Turkey, Switzerland, Spain, Saudi Arabia, Russia, Poland, Mexico and Korea, Italy, India, Greece, Germany, France, England, Canada, and Belgium.
The states and territories these words name
26 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Illinois
- Indiana
- Kansas
- Massachusetts
- Michigan
- Missouri
- Mississippi
- North Carolina
- New Jersey
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- Tennessee
- Texas
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Oct 31, 2014.
- FDA classified it on Nov 14, 2014.
- FDA’s Enforcement Report published it on Nov 26, 2014.
- FDA terminated it on Feb 20, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Accuray Incorporated, of Sunnyvale, CA.
- 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
-
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.