Ergon 2 Articulating Equipment Boom Monitor Brackets mounting point for display interfaces utilized in clinical applicat

FDA device recall Z-0655-2016 · posted 2016-01-14 · Terminated

Recall details

Recalling firm

Skytron, Div. The KMW Group, Inc

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.

Action taken

Skytron sent an Urgent Medical Device Recall letter dated December 02. 2015, to all affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with questions were instructed to contact at 616-656-2900 with any questions. For after-hours support, please call 1-800-SKYTRON.

Root cause

Device Design

Status

Terminated

Product code

FQO

Quantity affected

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.

Date initiated

2015-12-02

Date posted

2016-01-14

Date terminated

2016-07-19

Location

Grand Rapids, MI