FDA Device

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.

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.

What You Should Do

Remedy

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

Products

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
Brand
Accuray Incorporated
UPC
Model number: 025007

Units Affected

16 devices are subject to correction.