Summary
The FDA issued a Class II for Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount by IHB OPERATIONS B.V.. Reason: 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.
Details
Source
Device Recall
External ID
Z-1663-2025
Action Date
2025-04-30
Status
Ongoing
Category
device
Product Description
Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
Lot/Code Info: UDI/DI 10841736116071, All Serial Numbers
Quantity Affected: 112 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-03-27
Company
Zwolle, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 193 device recalls issued in the same week, part of 403 device-related FDA actions this month.
IHB OPERATIONS B.V. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (IHB OPERATIONS B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does IHB OPERATIONS B.V. have FDA actions?
IHB OPERATIONS B.V. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1663-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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