Recall Z-0828-2014— Accuray Incorporated

Name: FDA recall Z-0828-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-13

Class II · Terminated

Class II FDA medical device recall by Accuray Incorporated, initiated 2014-01-13, terminated 2014-11-25. It names one FDA 510(k) clearance: K122137. Product: Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.. Reason: Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching..

Recalling firm: Accuray Incorporated
Classification: Class II
Status: Terminated
Initiated: 2014-01-13
Terminated: 2014-11-25
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

Accuray CyberKnife Robotic Radiosurgery System; Accuray Incorporated Sunnyvale, CA. Indicated for treatment planning and image guided stereotactic radiosurgery and precision radiotherapy.

Reason for recall

Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one complaint of mounting assembly detaching.

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