RobotRisk Autonomous Systems Incident & Risk Register
RobotRiskAccuray › 27 Mar 2013

FDA Class II recall: RoboCouch Patient Positioning System

S3 · 27 Mar 2013 · Accuray

Record

CompanyAccuray
IndustryMedical robotics
Type(s)recall
Date27 Mar 2013 (day precision)
Time of daynot documented
Locationno physical site (recall / fleet-wide / aggregate record)
Severity (recall, enforcement, or fleet-wide fault)
ScaleRoboCouch Patient Positioning System
Confidencehigh
Verified flagYes - independently re-checked against the cited source

Summary

FDA enforcement record (Class II, recall Z-1155-2013): A5 gearboxes responsible for pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator may be defective.

Primary source

openFDA enforcement

Publisher: openFDA enforcement · Retrieved: 2026-09-16

Supporting source rows (1)
DateSupporting source rowPublisherLink
27 Mar 2013 FDA Class II recall: RoboCouch Patient Positioning System openFDA enforcement openFDA enforcement

Accuray other incidents timeline

Medical robotics context

recall context

Accuray industry position

Related incidents

Other Accuray entries

Report a correction

Open a prefilled GitHub issue

Also from Critical Systems Analysis: CSA - functional safety engineering · Company directory · FSTalent - functional safety jobs