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Recall Observatory FDA recall evidence

Device 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.

Z-0390-2017

October 05, 2016

Class II

Product summary

Firm
Maquet Medical Systems USA
Event
Event 75386
Status
Terminated
Classification
Class II
Quantity
9 Units (US) 141 Units (OUS)
Official record key
device-enforcement:Z-0390-2017

Official wording

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.

Code information: 600525A0

Distribution pattern: Worldwide Distribution - US Nationwide in the states of AZ, CA, DC, MI, MO, and PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.