Skytron, Div. The KMW Group, Inc: Medical Device Recall in 2016 - (Recall #: Z-0655-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 pendant / booms

Product Classification:

Class II

Date Initiated: December 2, 2015

Date Posted: January 20, 2016

Recall Number: Z-0655-2016

Event ID: 72897

Reason for Recall:

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.

Status: Terminated

Product Quantity: 286

Code Information:

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.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated