Company: Accuray Incorporated
Date of Enforcement Report 11/26/2014
Class lI:
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.
Recall Number Z-0218-2015
REASON
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.
RECALLING FIRM/MANUFACTURER
Accuray Incorporated, Sunnyvale, CA 10/31/2014. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
84 devices subject to correction.
DISTRIBUTION
Nationwide and Internationally
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