CLASS II Device recall · Reported 13 Mar 2019 · FDA Enforcement Report

Maquet XS Flat Screen Monitor Holder recalled by Getinge Us Sales

Getinge US Sales is recalling Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration, distributed in Arizona, Texas. The recall was initiated on 8 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 500001 500002 500003 500004 500005 500006

Quantity recalled6

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-0989-2019
FDA event ID: 82074
Recalling firm: Getinge US Sales, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 8 Jan 2019
FDA classified: 7 Mar 2019
Reported: 13 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

8 Jan 2019	Recall initiated by company
7 Mar 2019	Classified by FDA	+58 days
13 Mar 2019	Published in enforcement report	+6 days

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

Reason for recall

The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock under certain conditions while using the flat screen monitor holder with voltage of 100-220V.

Product as listed by the FDA

Maquet XS Flat Screen Monitor Holder, PWD70+DF HD R XS32 K3 SPE, Configuration Part Number ARD268400150A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.

Where it was distributed

The products were distributed to the following US states: AZ and TX.

Arizona Texas

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers 500001 500002 500003 500004 500005 500006

Where was it sold?

The products were distributed to the following US states: AZ and TX.

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

Other products in this recall event

3 other products · FDA event 82074

This product is part of a recall event; the main page for the event is Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration recalled.

Reported	Class	Recall	Company	Reason	Where
13 Mar 2019	CLASS II	Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration recalled	Getinge US Sales	Other	AZ, TX
13 Mar 2019	CLASS II	Maquet XS Flat Screen Monitor Holder, PWD50+DF XS32 K3 SPE recalled	Getinge US Sales	Other	AZ, TX
13 Mar 2019	CLASS II	Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration recalled	Getinge US Sales	Other	AZ, TX

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All 12

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