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U.S. Department of Health and Human Services

Class 2 Device Recall RoboCouch Patient Positioning System

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  Class 2 Device Recall RoboCouch Patient Positioning System see related information
Date Initiated by Firm March 27, 2013
Date Posting Updated April 20, 2013
Recall Status1 Terminated 3 on August 20, 2013
Recall Number Z-1155-2013
Recall Event ID 64809
510(K)Number K042146  
Product Classification Couch, radiation therapy, powered - Product Code JAI
Product RoboCouch Patient Positioning System


Product Usage: is 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 Model number: 025007
Recalling Firm/
Manufacturer
Accuray Incorporated
1310 Chesapeake Ter
Sunnyvale CA 94089-1100
For Additional Information Contact Joy M. Sacmar
408-716-4651
Manufacturer Reason
for Recall
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Accuray issued an Urgent Advisory Notification letter dated March 27, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated that Field Service Engineers will be replacing the affected product. Questions and concerns are to be directed to Accuray Customer Support at 1-877-668-8667
Quantity in Commerce 16 devices are subject to correction.
Distribution Worldwide Distribution - USA Nationwide including the states of: OH, MO. OK, CA and VA and the countries of: Finland, France, Luxembourg, Poland, Russia, Turkey and Japan.
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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