Recall Record

Zwolle, Netherlands

IHB OPERATIONS B.V. recalls

2 recalls recorded since 2018, most recently on 27 March 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.

Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
27 March 2025
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 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.
Initiated
Voluntary: Firm initiated
Recall number
Z-1663-2025

Ongoing Class II Medical devices

Recall started
19 July 2023
Reason
Weakened connection point on the adjustable suspension arm, potentially causing damage or a break.
Distribution
US: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MB, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, WI, WV.
Initiated
Voluntary: Firm initiated
Recall number
Z-0452-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.