FDA recall Z-0989-2019

GETINGE US SALES LLC · Class II · device

Product

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.

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.

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-01-08
Report date
2019-03-13
Termination date
2020-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0989-2019