CLASS II Device recall · Reported 17 Feb 2016 · FDA Enforcement Report

CyberKnife Robotic recalled by Accuray Incorporated

Accuray Incorporated is recalling CyberKnife Robotic, distributed nationwide in the US. The recall was initiated on 22 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog/part numbers 032000 and 033000; Serial numbers: United States: C0063 C0064 C0074 C0088 C0090 C0091 C0092 C0095 C0096 C0098 C0099 C0100 C0101 C0102 C0103 C0104 C0106 C0108 C0111 C0112 C0114 C0118 C0119 C0123 C0126 C0127 C0128 C0131 C0133 C0134 C0135 C0136 C0137 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0162 C0163 C0165 C0172 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 C0224 C0226 C0233 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0328 C0353 C0355 C0124: International: C0170 C0171 C0180 C0216 C0236 C0264 C0269 C0326 C0204 C0125 C0175 C0189 C0191 C0215 C0227 C0279 C0315 C0166 C0147 C0168 C0187 C0105 C0242 C0185 C0286 C0306 C0188 C0218 C0237 C0240 C0265 C0268 C0288 C0314 C0324 C0251 C0272 C0322 C0153 C0289 C0235 C0267 C0120 C0138 C0148 C0157 C0212 C0229 C0239 C0297 C0241 C0281 C0300 C0307 C0308 C0313 C0320 C0327 C0329 C0331 C0333 C0340 C0341 C0347 C0350 C0392 C0115 C0117 C0154 C0161 C0228 C0255 C0266 C0270 C0294 C0339 C0176 C0195 C0309 C0319 C0321 C0093 C0221 C0234 C0249 C0275 C0277 C0299 C0305 C0325 C0110 C0113 C0130 C0232 C0245 C0276 C0287 C0295 C0217 C0282 C0107 C0258 C0271 C0280 C0298 C0301 C0302 C0310 C0317 C0357 C0365 C0202 C0231 C0238 C0230.

Quantity recalled226

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0771-2016
FDA event ID: 73193
Recalling firm: Accuray Incorporated, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 22 Jan 2016
FDA classified: 8 Feb 2016
Reported: 17 Feb 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

22 Jan 2016	Recall initiated by company
8 Feb 2016	Classified by FDA	+17 days
17 Feb 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery System 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.

Where it was distributed

Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium.

Nationwide

Questions about this recall

Is CyberKnife Robotic recalled?

Yes. Accuray Incorporated recalled CyberKnife Robotic on 22 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-0771-2016.

Why was it recalled?

Which lots are affected?

Catalog/part numbers 032000 and 033000; Serial numbers: United States: C0063 C0064 C0074 C0088 C0090 C0091 C0092 C0095 C0096 C0098 C0099 C0100 C0101 C0102 C0103 C0104 C0106 C0108 C0111 C0112 C0114 C0118 C0119 C0123 C0126 C0127 C0128 C0131 C0133 C0134 C0135 C0136 C0137 C0143 C0144 C0146 C0149 C0150 C0151 C0152 C0155 C0158 C0159 C0162 C0163 C0165 C0172 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 C0224 C0226 C0233 C0244 C0246 C0247 C0248 C0252 C0253 C0254 C0256 C0259 C0260 C0261 C0262 C0263 C0273 C0274 C0278 C0283 C0284 C0285 C0290 C0291 C0293 C0296 C0303 C0304 C0312 C0316 C0323 C0328 C0353 C0355 C0124: International: C0170 C0171 C0180 C0216 C0236 C0264 C0269 C0326 C0204 C0125 C0175 C0189 C0191 C0215 C0227 C0279 C0315 C0166 C0147 C0168 C0187 C0105 C0242 C0185 C0286 C0306 C0188 C0218 C0237 C0240 C0265 C0268 C0288 C0314 C0324 C0251 C0272 C0322 C0153 C0289 C0235 C0267 C0120 C0138 C0148 C0157 C0212 C0229 C0239 C0297 C0241 C0281 C0300 C0307 C0308 C0313 C0320 C0327 C0329 C0331 C0333 C0340 C0341 C0347 C0350 C0392 C0115 C0117 C0154 C0161 C0228 C0255 C0266 C0270 C0294 C0339 C0176 C0195 C0309 C0319 C0321 C0093 C0221 C0234 C0249 C0275 C0277 C0299 C0305 C0325 C0110 C0113 C0130 C0232 C0245 C0276 C0287 C0295 C0217 C0282 C0107 C0258 C0271 C0280 C0298 C0301 C0302 C0310 C0317 C0357 C0365 C0202 C0231 C0238 C0230.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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