The Recall Desk
HighFDA (Devices)·Z-0655-2016·Announced 2016-01-20

Skytron Ergon 2 Monitor Brackets Recalled Due to Hardware Failure Risk

Skytron is recalling 286 Ergon 2 monitor brackets because hardware may fail, causing displays to fall and potentially injure patients or providers.

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: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Skytron, Div. The KMW Group, Inc. is recalling 286 units of the Ergon 2 Articulating Equipment Boom Monitor Brackets. These brackets serve as mounting points for display interfaces used in clinical applications and provide an articulating point of movement on ceiling-mounted radial arm suspension systems. The affected model numbers are H8-010-50-FC2-LH and H8-010-50-FC2-RH, with VESA plates distributed between September 26, 2008, and April 30, 2013.

The recall is due to a defect where the hardware holding the VESA plate and display interface to the bracket may fail. Over time and with use, the threaded rod hardware material can weaken and detach from the bracket. This failure may cause the display interface to fall from its mounting location, which may result in injury to the patient or provider.

The affected units were distributed worldwide, including in the United States (specifically WI, TX, FL, NC, MD, OH, AZ, CA, UT, MT, OK, HI, CO, WY, MO, NJ, IL, NY, MA, IA, DE, PA, MI, IN, and WV) and internationally to Canada and Japan. Consumers and healthcare facilities should contact Skytron for instructions on how to address this issue.

The recalled product

Product
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and to provide an articulating point of movement on the ceiling mounted radial arm suspension system of the Ergon 2 equipment penda
Affected units
286

Distribution

Same manufacturer · Skytron, Div. The KMW Group, Inc

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