Medical device recalls Moderate risk

Maquet Medical Systems USA recalls Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovetail…

Recall date
October 5, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0390-2017
FDA classification
Class II
Brand / firm
Maquet Medical Systems USA
Sold / distributed
Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA

Why it was recalled

Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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