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Terminated

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.

FDA Recall Z-0218-2015 · Posted 2014-11-14

Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2014-10-31
Date Terminated2015-02-20
Product Quantity84 devices subject to correction.

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K122137CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEMAccuray Incorporated · 2012-10-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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