CLASS II Device recall · Reported 16 Nov 2016 · FDA Enforcement Report

Accessory Adapter recalled by Maquet Medical Systems U

Maquet Medical Systems U is recalling Accessory Adapter, distributed nationwide in the US. The recall was initiated on 5 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes600525A0

Quantity recalled9 Units (US) 141 Units (OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0390-2017
FDA event ID: 75386
Recalling firm: Maquet Medical Systems U, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Oct 2016
FDA classified: 9 Nov 2016
Reported: 16 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

5 Oct 2016	Recall initiated by company
9 Nov 2016	Classified by FDA	+35 days
16 Nov 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Arizona California District of Columbia Michigan Missouri Pennsylvania

Questions about this recall

Is Accessory Adapter recalled?

Yes. Maquet Medical Systems U recalled Accessory Adapter on 5 Oct 2016. The recall is Class II and its status is Terminated. Recall number Z-0390-2017.

Why was it recalled?

Which lots are affected?

600525A0

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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