Skytron Freedom Monitor Mount Recall: Inadequate Mounting Hardware
IHB OPERATIONS B.V. is recalling 112 Skytron Freedom 4FXS-60 monitor mounts due to inadequate thread engagement in the mounting hardware, which could lead to equipment failure and separation from the mounting column.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of medical equipment with risk of structural failure and falling monitor frame. No deaths or reported injuries have been documented. Meets 'High' severity as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
IHB OPERATIONS B.V. is recalling 112 units of the Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount, distributed nationwide across 24 states including AL, AZ, CA, FL, IA, ID, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NM, NY, PA, TN, TX, UT, VA, WI, and WV. All units are affected and identified by UDI/DI 10841736116071 and all serial numbers.
The mounting hardware supplied with these monitor brackets does not provide adequate thread engagement to properly support the weight of the frame and monitor. This inadequate thread engagement could result in failure of the mounting hardware and subsequent separation of the monitor frame from the mounting column.
Healthcare facilities and organizations that have received this monitor mount should immediately cease using the affected units and contact IHB OPERATIONS B.V. for replacement hardware or further instructions. Do not attempt to modify or repair the existing mounting hardware.
The recalled product
- Product
- Skytron Freedom 4FXS-60 Heavy Duty Monitor Mount
- Manufacturer
- IHB OPERATIONS B.V.
- Hazard
- mounting-failure
- fall-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10841736116071
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
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