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U.S. Department of Health and Human Services

Class 2 Device Recall CyberKnife Robotic Radiosurgery System with IRIS Variable Aperture Collimator.

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  Class 2 Device Recall CyberKnife Robotic Radiosurgery System with IRIS Variable Aperture Collimator. see related information
Date Initiated by Firm October 31, 2014
Date Posted November 14, 2014
Recall Status1 Terminated 3 on February 20, 2015
Recall Number Z-0218-2015
Recall Event ID 69645
510(K)Number K122137  
Product Classification Accelerator, linear, medical - Product Code IYE
Product 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.
Code Information 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. 
Recalling Firm/
Manufacturer		 Accuray Incorporated
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact Joy Sacmar
408-716-4600
Manufacturer 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.
FDA Determined
Cause 2		 Software design
Action Accuray sent an Urgent Safety Advisory Notification letter dated October 17, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the radiaiton field size (beam width) for each Iris setting to ensure that it matches the beam commissioning data in the MultiPlan System to within the stated tolerance of 0.2 mm. Customers with questions were instructed to contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solutions Center at www.accuray.com or call North America: +1.877.668.8667, Europe: +800.4141.9595, Hong Kong +852.2247.8688, Japan +81.3.6269.9556. For questions regarding this recall call 408-716-4600.
Quantity in Commerce 84 devices subject to correction.
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = ACCURAY INCORPORATED
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