CLASS II Device recall · Reported 1 May 2013 · FDA Enforcement Report

RoboCouch Patient Positioning System recalled by Accuray Incorporated

Accuray is recalling RoboCouch Patient Positioning System, distributed nationwide in the US. The recall was initiated on 27 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number: 025007

Quantity recalled16 devices are subject to correction.

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1155-2013
FDA event ID: 64809
Recalling firm: Accuray, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 27 Mar 2013
FDA classified: 19 Apr 2013
Reported: 1 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

27 Mar 2013	Recall initiated by company
19 Apr 2013	Classified by FDA	+23 days
1 May 2013	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide California Missouri Ohio Virginia

Questions about this recall

Why was it 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.

Which lots are affected?

Model number: 025007

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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