Skytron, Div. The KMW Group, Inc recalls Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applica…

Recall date

December 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0655-2016

FDA classification

Class II

Brand / firm

Skytron, Div. The KMW Group, Inc

Sold / distributed

Worldwide Distribution - US including WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV and Internationally to Canada, and Japan.

Why it was recalled

The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider.

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

What was recalled

Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment pendant / booms