Events

Recall of UltraLite Vehicles powered by Rascal Motorized Vehicles.

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
    32657
  • Event Risk Class
    Class 2
  • Event Number
    Z-1376-05
  • Event Initiated Date
    2005-05-05
  • Event Date Posted
    2005-08-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40497
  • 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
    Wheelchair, Powered - Product Code ITI
  • Reason
    The engager set screw may become loose. this problem may cause the potentiometer to become off-center thus affecting the end users stopping capabilities.
  • Action
    The firm sent out letters to their customers on 4/20/2005. The firm's sales representatives were also notified on 4/20/2005.

Device

UltraLite Vehicles powered by Rascal Motorized Vehicles.
  • Model / Serial
    All units distributed under Model Number UL370.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm sells the vehicles via direct sales to end customers and also to company owned inventory with sales representatives. The distribution is nationwide.
  • Product Description
    UltraLite Vehicles powered by Rascal Motorized Vehicles.
  • Manufacturer
    Electric Mobility Corp

Manufacturer

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