Events

Recall of Device Recall 2 over 2 Elevating Monitor Suspension

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Omega Medical Imaging, 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
    74886
  • Event Risk Class
    Class 2
  • Event Number
    Z-2734-2016
  • Event Initiated Date
    2016-06-21
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148678
  • 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
    unknown device name - Product Code N/A
  • Reason
    Elevating monitor suspension separated from the lifting column bracket.
  • Action
    Consignees were notified by a Field Safety Advisory Notice - FSAN 16-0001 of this immediate Recall on 6/21/2016.

Device

Device Recall 2 over 2 Elevating Monitor Suspension
  • Model / Serial
    Model: Elevating Monitor Suuspension P/Ns: 1000-0085, 1000-0095 and (1000-0129 one unit produced does not use bracket 1040-0071 or 1040-0031).
  • Distribution
    CO, MN, GA, NC, IN, OH, KY, IL, NY, AL, MO, LA, PA, and SD Denmark
  • Product Description
    2 over 2 Elevating Monitor Suspension - Omega Medical Imaging, LLC Elevating Monitor Suspension Systems.
  • Manufacturer
    Omega Medical Imaging, Inc.

Manufacturer

Omega Medical Imaging, Inc.
  • Manufacturer Address
    Omega Medical Imaging, Inc., 675 Hickman Cir, Sanford FL 32771-6931
  • Source
    USFDA