RobotRisk / Accuray / 2013-03-27

medical robotics · recall

FDA Class II recall: RoboCouch Patient Positioning System

S3 · 03/27
2013 · Accuray

Record

Company	Accuray
Category	medical robotics
Type	recall
Date	03/27 2013
Time of day	not documented
Location	no physical site (recall / fleet-wide / aggregate record)
Severity	S3 (recall, enforcement, or fleet-wide fault)
Scale	RoboCouch Patient Positioning System
Confidence	high
Verification	Yes - adversarially checked against the cited source
Source	openFDA enforcement

What happened

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.

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S3	2025-02-26	Intuitive Surgical	Class II recall of da Vinci 5 foot pedal over spring failure

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