Medical device recalls Moderate risk

GETINGE US SALES LLC recalls Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is d…

Recall date
January 8, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0987-2019
FDA classification
Class II
Brand / firm
GETINGE US SALES LLC
Sold / distributed
The products were distributed to the following US states: AZ and TX.

Why it was recalled

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.

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

What was recalled

Maquet XS Flat Screen Monitor Holder, XS32 SPE, Configuration Part Number ARD22201040A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.

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