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U.S. Department of Health and Human Services

Class 2 Device Recall RoboCouch Patient Support System, a subsystem of the Cyberknife Robotic Radiosurgery System

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  Class 2 Device Recall RoboCouch Patient Support System, a subsystem of the Cyberknife Robotic Radiosurgery System see related information
Date Initiated by Firm July 21, 2009
Date Posted January 11, 2011
Recall Status1 Terminated 3 on January 12, 2011
Recall Number Z-0853-2011
Recall Event ID 53047
510(K)Number K072504  K042146  
Product Classification Powered Radiation Therapy Couch - Product Code JAI
Product RoboCouch Patient Support System, model number 025007, a subsystem of the Cyberknife Robotic Radiosurgery System, manufactured by Accuray Incorporated, Sunnyvale, CA.

Intended for use in the support and positioning of a patient during Radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
Code Information RoboCouch model 025007
Recalling Firm/
Manufacturer
Accuray Inc
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact
408-716-4600
Manufacturer Reason
for Recall
Mechanical Failure-- Patient Support System's table top may unexpectedly descend several inches.
FDA Determined
Cause 2
Device Design
Action Consignees were notified verbally about the issue when an inspection was scheduled.
Quantity in Commerce 26
Distribution Worldwide Distribution -- USA, including states of CA, FL, VA, AL, CT, MA, NC, TN, PA, RI, and NE and countries of Turkey, France, UK, Saudi Arabia, and Switzerland.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAI and Original Applicant = ACCURAY INCORPORATED
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