FDAClass IIJanuary 20, 2016

Ergon 2 Articulating Equipment Boom Monitor Brackets recall

Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and…

Why was Ergon 2 Articulating Equipment Boom Monitor Brackets recalled?

The hardware that holds the VESA plate and the display interface / monitor to the bracket may fail causing the display interface to fall from the bracket. Over time and with use the threaded rod hardware material can weaken and detach from the bracket. A display interface falling from its mounting location may result in injury to the patient or provider.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number(s): H8-010-50-FC2-LH and H8-010-50-FC2-RH. VESA plates distributed from 09/26/08 to 04/30/13.

Product
Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applications for viewing purposes and…
Recalling firm
Skytron, Div. The KMW Group, Inc
Quantity
286
Distribution
Worldwide Distribution - US including 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.
Recall date
January 20, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls