Events

Recall of Device Recall 3wheeled electric scooter, model HMV 250

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Tung Keng Enterprise Co., Ltd..

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
    34405
  • Event Risk Class
    Class 2
  • Event Number
    Z-0522-06
  • Event Initiated Date
    2005-11-01
  • Event Date Posted
    2006-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43788
  • 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
    The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
  • Action
    The recalling firm sent field correction instructions to their customers on or about 11/1/05.

Device

Device Recall 3wheeled electric scooter, model HMV 250
  • Model / Serial
    All serial numbers 04H86001 to 05A468246.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to OHL/Invacare, Rancho Technology Park Bldg. B 8950, Rancho Cucamonga, CA 91730; OHL/Invacare, 1100 Whitaker Road, Plainfield, IN 46168; Invacare Corporation, 39400 Taylor Parkway North Ridgeville, OH 44039; and Invacare, Dallas Texas Distribution Center, 3460 South Watson Rd., Arlington, TX 76014.
  • Product Description
    The product is a mobile 3-wheeled electric scooter, model HMV 250. The product contains either a red or blue base. The red base is identified with SKU #915363224. The blue base is identified with SKU #915363225. The product is distributed by the Invacare Corporation.
  • Manufacturer
    Tung Keng Enterprise Co., Ltd.

Manufacturer

Tung Keng Enterprise Co., Ltd.
  • Manufacturer Address
    Tung Keng Enterprise Co., Ltd., No.1, Lane 160, Section 2,, Tan-Fu Road, Tai-Tzu Hsiang, Taichung County Taiwan
  • Source
    USFDA