FDAClass IIMay 1, 2013

RoboCouch Patient Positioning System Product Usage: is recall

RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and…

Why was RoboCouch Patient Positioning System Product Usage: is recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model number: 025007

Product
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and…
Recalling firm
Accuray Incorporated
Quantity
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.
Recall date
May 1, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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