The Recall Desk
HighFDA (Devices)·Z-0390-2017·Announced 2016-11-16

Maquet Accessory Adapter Recalled Due to Head Rest Slipping Hazard

Maquet Medical Systems USA is recalling Accessory Adapter part number 600525A0 because a head rest mounted to the device slipped out of the mounting rail.

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 involves a medical device with a mechanical defect that could cause injury, but the source text does not explicitly report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Maquet Medical Systems USA is initiating a voluntary field action for the Accessory Adapter, part number 600525A0. This medical device is designed for mounting MAQUET accessories with a dovetail guide interface during surgical interventions, examinations, and treatments.

The recall was initiated due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mounting rail. This incident highlights a potential mechanical failure risk associated with the device's mounting interface.

The recall affects 9 units in the United States and 141 units outside the US. Distribution in the US was nationwide, specifically in the states of Arizona, California, the District of Columbia, Michigan, Missouri, and Pennsylvania. Users of this device should contact Maquet Medical Systems USA for further instructions regarding the field action.

The recalled product

Product
Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail guide interface immediately before, during and after surgical interventions as well as for examination and treatment.

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)

  • 600525A0

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically: