CLASS II Device recall · Reported 26 Nov 2014 · FDA Enforcement Report

CyberKnife Robotic Radiosurgery System recalled by Accuray Incorporated

Accuray is recalling CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture, distributed in 26 states. The recall was initiated on 31 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog/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.

Quantity recalled84 devices subject to correction.

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-0218-2015
FDA event ID: 69645
Recalling firm: Accuray, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 31 Oct 2014
FDA classified: 14 Nov 2014
Reported: 26 Nov 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

31 Oct 2014	Recall initiated by company
14 Nov 2014	Classified by FDA	+14 days
26 Nov 2014	Published in enforcement report	+12 days

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

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

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

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

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.

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 26 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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