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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 Recall
RoboCouch Patient Positioning System
see related information
Date Posted April 20, 2013
Recall Status1 Terminated on August 20, 2013
Recall Number Z-1155-2013
Recall Event ID 64809
Premarket Notification
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, California 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JAI and Original Applicant = ACCURAY INCORPORATED
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