Accuray CyberKnife Robotic Radiosurgery System
Medical device recall Z-0828-2014. Published in FDA’s Enforcement Report on Feb 5, 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 Feb 5, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 302 devices; 149 in US, 153 out of US. 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?
Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.
302 devices; 149 in US, 153 out of US., in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part number: 054000-001; Serial numbers in US: C0022 C0030 C0037 C0042 C0045 C0046 C0047 C0048 C0049 C0051 C0052 C0053 C0055 C0056 C0057 C0058 C0059 C0061 C0062 C0063 C0064 C0067 C0068 C0070 C0071 C0072 C0074 C0078 C0079 C0080 C0088 C0090…
Every code shown here, 1,868 characters
Part number: 054000-001; Serial numbers in US: C0022 C0030 C0037 C0042 C0045 C0046 C0047 C0048 C0049 C0051 C0052 C0053 C0055 C0056 C0057 C0058 C0059 C0061 C0062 C0063 C0064 C0067 C0068 C0070 C0071 C0072 C0074 C0078 C0079 C0080 C0088 C0090 C0091 C0092 C0094 C0095 C0097 C0098 C0099 C0100 C0101 C0102 C0103 C0106 C0108 C0109 C0111 C0112 C0114 C0118 C0119 C0122 C0123 C0126 C0127 C0128 C0131 C0132 C0133 C0134 C0135 C0136 C0137 C0139 C0141 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0160 C0162 C0163 C0165 C0174 C0177 C0178 C0179 C0181 C0182 C0183 C0184 C0186 C0192 C0194 C0196 C0197 C0198 C0199 C0200 C0201 C0203 C0205 C0206 C0207 C0208 C0209 C0210 C0213 C0214 C0219 C0220 C0222 C0223 C0224 C0225 C0226 C0233 C0243 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0257 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0332 C0335 C0336 C0338 C0343 C0124 Out of US: C0202 C0231 C0238 C0351 C0170 C0171 C0235 C0267 C0282 TBD C0032 C0054 C0060 C0093 C0105 C0110 C0113 C0115 C0117 C0125 C0130 C0154 C0161 C0175 C0176 C0180 C0185 C0187 C0188 C0189 C0191 C0195 C0204 C0211 C0215 C0216 C0217 C0218 C0221 C0227 C0228 C0230 C0232 C0234 C0236 C0237 C0240 C0242 C0245 C0249 C0251 C0255 C0264 C0265 C0266 C0268 C0269 C0270 C0272 C0275 C0276 C0277 C0279 C0286 C0287 C0288 C0292 C0294 C0295 C0299 C0305 C0306 C0309 C0314 C0315 C0319 C0321 C0322 C0324 C0325 C0326 C0330 C0334 C0337 C0339 C0342 C0344 C0348 C0349 C0006 C0007 C0008 C0012 C0013 C0014 C0019 C0020 C0033 C0190 C0193 C0241 C0281 C0300 C0307 C0308 C0313 C0320 C0327 C0329 C0331 C0333 C0340 C0341 C0347 C0038 C0041 C0065 C0073 C0075 C0076 C0077 C0084 C0085 C0086 C0087 C0089 C0107 C0120 C0121 C0138 C0140 C0145 C0147 C0148 C0157 C0166 C0168 C0169 C0173 C0212 C0229 C0239 C0258 C0271 C0280 C0289 C0297 C0298 C0301 C0302 C0310 C0317 C0345.
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. - US (Nationwide) and Mexico; and Internationally to: Australia, Belgium, Canada, China, Colombia, Czech Republic, England, Finland, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Malaysia, Luxembourg, Netherlands, Poland, Russia, Saudia Arabia, Spain, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela, and Vietnam
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?
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 Jan 13, 2014.
- FDA classified it on Jan 27, 2014.
- FDA’s Enforcement Report published it on Feb 5, 2014.
- FDA terminated it on Nov 25, 2014.
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
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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.