Z-1155-2013Class II

RoboCouch Patient Positioning System

Name: Z-1155-2013 RoboCouch Patient Positioning System
Creator: Accuray Incorporated
Published: 2013-03-27
License: https://open.fda.gov/license/

Accuray Incorporated / initiated 2013-03-27 / Terminated / root cause: manufacturing process

FDA source

Accuray Incorporated began a recall of RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy... on 2013-03-27. FDA classified it as Class II and gives the reason as "A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1155-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-27
Posted: 2013-04-20
Terminated: 2013-08-20
Recalling firm: Accuray Incorporated
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.
Product code: JAI Couch, Radiation Therapy, Powered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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
Quantity in commerce: 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.
Product codes and lots: Model number: 025007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1155-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1155-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-19

Product code JAI

K042146Class IIRobocouch Patient Support SystemAccuray Incorporated / cleared 2004-09-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)