Events

Recall of Device Recall 2 over 2 elevating monitor suspension system

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
    77458
  • Event Risk Class
    Class 2
  • Event Number
    Z-2621-2017
  • Event Initiated Date
    2017-03-23
  • Event Date Posted
    2017-06-19
  • 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=156081
  • 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
    Monitor, patient position, light-beam - Product Code IWE
  • Reason
    Elevating monitor suspension column dropping and will not rise back up.
  • Action
    The firm, OMEGA MEDICAL IMAGING, sent a "Field Safety Advisory Notice" dated 3/23/2017 to consignees. The notice described the product, problem and actions to be taken. The consignees were instructed to immediately examine the product and confirm correct product information; immediately discontinue use; move monitor suspension away from staff personnel and patients; and advising consignees to take photos of affected product and the P/N label. Photos of product labels are to be sent to jnewman@omegamedicalimaging.com at Omega. Product is to be corrected. If there are any questions or concerns, please feel free to contact us at 407-323-9400 Ext 203 or email: omegamedicalimaging.com or jnewman@omegamedicalimaging.com.

Device

Device Recall 2 over 2 elevating monitor suspension system
  • Model / Serial
    SKF Telescopic Pillar P/N ending in -003
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -US Distribution to states of: IN, OH, PA, and MT; and country of: Pakistan.
  • Product Description
    Omega Medical Imaging - 2 over 2 Elevating Monitor Suspension pillar/column accessory || Device accessory that elevates monitor for healthcare professionals.
  • 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