Events

Recall of Device Recall Skytron Ergon 2 Skyboom

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Skytron, Div. The KMW Group, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72897
  • Event Risk Class
    Class 2
  • Event Number
    Z-0655-2016
  • Event Initiated Date
    2015-12-02
  • Event Date Posted
    2016-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142447
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Table, operating-room, ac-powered - Product Code FQO
  • Reason
    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
    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.

Device

Device Recall Skytron Ergon 2 Skyboom
  • Model / Serial
    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 Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • 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
  • Manufacturer
    Skytron, Div. The KMW Group, Inc

Manufacturer

Skytron, Div. The KMW Group, Inc
  • Manufacturer Address
    Skytron, Div. The KMW Group, Inc, 5085 Corporate Exchange Blvd Se, Grand Rapids MI 49512-5515
  • Manufacturer Parent Company (2017)
    The Kmw Group Inc
  • Source
    USFDA