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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Event Detail

Event ID 64809
Product Type Devices
Status Ongoing
Recalling Firm Accuray Incorporated
City Sunnyvale
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model number: 025007 Class II A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective. 16 devices are subject to correction. Z-1155-2013