Recall Z-1663-2025— IHB OPERATIONS B.V.
Class II · Ongoing
Class II FDA medical device recall by IHB OPERATIONS B.V., initiated 2025-03-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount. 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..
- Recalling firm
- IHB OPERATIONS B.V.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-27
- Firm location
- Zwolle, N/A, Netherlands
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.