Events

Recall of Rascal LiteWay Scooter Model 224

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Electric Mobility Corp.

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
    56978
  • Event Risk Class
    Class 2
  • Event Number
    Z-0416-2011
  • Event Date Posted
    2010-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95193
  • 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
    Vehicle, motorized 3-wheeled - Product Code INI
  • Reason
    Scooter seat bases were found to have insufficient welding which may lead to the seat base becoming loose and causing the seat to wobble. this may result in complete failure of the seat base, causing the user to fall off the vehicle.
  • Action
    The Rascal Company (Electric Mobility Corporation) sent Urgent Medical Device Recall Notice Scooter Seat Base letters dated October 7, 2010 and November 11, 2010 letter to their affected retail customers and affected dealers. The letter instructs the reader that the seat base may become loose, causing the seat to wobble and if not replaced the wobble could lead to a complete failure of the seat base and cause an individual to fall off their vehicle and become injured. The letters also instruct the reader to replace seat bases immediately. Respone forms are attached. Seats with new seat bases will be shipped with return shipping labels to return the original base to the factory. Service representatives will replace the seat base for customers. Customers can contact the Rascal Company about this recall at 1-800-662-4548.

Device

Rascal LiteWay Scooter Model 224
  • Model / Serial
    No expiration date; 510 K - K002616; Device Listing #E394292; LW224, EMC Part #43062300, EMC Part #43062700
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Throughout the US and Canada
  • Product Description
    Rascal LiteWay 224 manufactured by Giant Manufacturing, Taiwan.
  • Manufacturer
    Electric Mobility Corp

Manufacturer

Electric Mobility Corp
  • Manufacturer Address
    Electric Mobility Corp, 599 Mantua Boulevard, One Mobility Plaza, Sewell NJ 08080
  • Source
    USFDA