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Recall Observatory FDA recall evidence

Device product

Maquet XS Flat Screen Monitor Holder, SAT XS32 12 SPE, Configuration Part Number ARD2SAT00130A Product Usage: This product is designed to support one or two medical grade flat screen(s) alone or in association with surgical lights.

Z-0990-2019

January 08, 2019

Class II

Product summary

Firm
GETINGE US SALES LLC
Event
Event 82074
Status
Terminated
Classification
Class II
Quantity
4
Official record key
device-enforcement:Z-0990-2019

Official wording

Reason: 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.

Code information: Serial Numbers 500013 500014 500096 500097

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.