Recall Z-0218-2015— Accuray Incorporated

Name: FDA recall Z-0218-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-31

Class II · Terminated

Class II FDA medical device recall by Accuray Incorporated, initiated 2014-10-31, terminated 2015-02-20. It names one FDA 510(k) clearance: K122137. 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.. 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: Accuray Incorporated
Classification: Class II
Status: Terminated
Initiated: 2014-10-31
Terminated: 2015-02-20
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K122137 — CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEMAccuray Incorporated·cleared 2012-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.