Recall Z-0390-2017— Maquet Medical Systems USA

Class II · Terminated

Class II FDA medical device recall by Maquet Medical Systems USA, initiated 2016-10-05, terminated 2018-02-02. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm
Maquet Medical Systems USA
Classification
Class II
Status
Terminated
Initiated
2016-10-05
Terminated
2018-02-02
Firm location
Wayne, NJ, United States

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.