CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is in
FDA device recall Z-0218-2015 · posted 2014-11-14 · Terminated
Recall details
- Recalling firm
- Accuray Incorporated
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 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
- Date initiated
- 2014-10-31
- Date posted
- 2014-11-14
- Date terminated
- 2015-02-20
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM (K122137) | Accuray Incorporated | 2012-10-26 |