Home / Recalls / Medical Devices
Accuray Incorporated recalls RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patien
Recalled May 1, 2013 · FDA recall Z-1155-2013 · Accuray Incorporated
Hazard
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 Class II
Units
16 devices are subject to correction.
Sold at
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.
Description
A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.
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.
Manufacturer(s)
Accuray Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →