Events

Recall of Omega Incline Platform Lift

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Savaria Concord Lifts, 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
    77053
  • Event Risk Class
    Class 2
  • Event Number
    Z-1880-2017
  • Event Initiated Date
    2017-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154907
  • 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
    Transport, patient, powered - Product Code ILK
  • Reason
    Savaria concord lifts inc has decided to initiate this recall of its omega incline platform lift because bolts can come loose causing the carriage to separate from the trolley and the unit to fail.
  • Action
    Savaria Concord Lifts Inc contacted the dealers to insure they received the parts and instructions and ask if they understand what is requested. If the dealers indicated they could no longer find the required parts new kits and instructions were sent on April 2015. Savaria Concord Lifts Inc contacted the dealers via e-mail and phone. For further questions, please call (800) 661-5112.

Device

Omega Incline Platform Lift
  • Model / Serial
    s/n or lot number - Job Number 630046 through 630119
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to North America.
  • Product Description
    Omega Incline Platform Lift
  • Manufacturer
    Savaria Concord Lifts, Inc.

Manufacturer

Savaria Concord Lifts, Inc.
  • Manufacturer Address
    Savaria Concord Lifts, Inc., 2 Walker Dr, Brampton Canada
  • Manufacturer Parent Company (2017)
    Savaria Corp.
  • Source
    USFDA