The Recall Desk
HighFDA (Devices)·Z-1155-2013·Announced 2013-05-01

Accuray RoboCouch Patient Positioning System Recalled for Defective Gearboxes

Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems because A5 gearboxes responsible for pitch and roll motions may be defective.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a defect in a medical device used for precise patient positioning without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems. The recall is due to a defect in the A5 gearboxes, which are responsible for the pitch (head up and head down) and roll (patient left and right) motions of the RoboCouch manipulator.

The RoboCouch Patient Positioning System 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. The affected devices are identified by model number 025007.

The recall covers devices distributed worldwide, including the United States (specifically Ohio, Missouri, Oklahoma, California, and Virginia) and the countries of Finland, France, Luxembourg, Poland, Russia, Turkey, and Japan. No specific instructions for consumers or healthcare providers are provided in the source text.

The recalled product

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.
Manufacturer
Accuray Incorporated
Category
Medical Device — Radiation Therapy Equipment
Hazard
Affected units
16

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model number: 025007

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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