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Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

FDA Recall #Z-1663-2025 — Class II — March 27, 2025

Recall #Z-1663-2025 Date: March 27, 2025 Classification: Class II Status: Ongoing

Product Description

Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount

Reason for Recall

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.

Recalling Firm

IHB OPERATIONS B.V. — Zwolle, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

112 units

Distribution

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.

Code Information

UDI/DI 10841736116071, All Serial Numbers

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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