Medical device recalls Moderate risk

IHB OPERATIONS B.V. recalls Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

Recall date
March 27, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1663-2025
FDA classification
Class II
Brand / firm
IHB OPERATIONS B.V.
Sold / distributed
US Nationwide distribution including in the states of AL, AZ, CA, FL, IA, ID, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NM, NY, PA, TN, TX, UT, VA, WI, WV.

Why it was recalled

The mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the frame and monitor. This could lead to a failure of the mounting hardware and subsequent separation of the frame from the mounting column.

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

What was recalled

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

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