Z-1663-2025 Class II Ongoing

Recalled by IHB OPERATIONS B.V. — Zwolle, N/A

FDA device recall Z-1663-2025 was initiated by IHB OPERATIONS B.V. on March 27, 2025 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 112 units.

Recall Details

Product Type
Devices
Report Date
April 30, 2025
Initiation Date
March 27, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
112 units

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.

Distribution Pattern

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