Events

Recall of Device Recall Golden Buzzaround XL

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Golden Technologies, 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
    67416
  • Event Risk Class
    Class 2
  • Event Number
    Z-1235-2014
  • Event Initiated Date
    2014-01-21
  • Event Date Posted
    2014-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125418
  • 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
    Buzzaround xl scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw.
  • Action
    Golden Technologies sent a recall notification letter, dated January 14, 2014 to providers/dealers. A second letter, dated January 21, 2014 was sent to these same customers. Based on a slow initial response, the firm intends to send out the correction kit with the inspection acknowledgement form as soon as possible. Based on the overall response from dealers, a third consumer letter was drafted (notification3) for mailing directly to known consumers, if necessary. For help contact a special technical service hotline at 1-800-624-6374 ext. 392.

Device

Device Recall Golden Buzzaround XL
  • Model / Serial
    GB 116 and GB146 series, with multiple serial numbers
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    Buzzaround XL scooters' || Product Usage: mobility
  • Manufacturer
    Golden Technologies, Inc.

Manufacturer

Golden Technologies, Inc.
  • Manufacturer Address
    Golden Technologies, Inc., 401 Bridge St, Old Forge PA 18518-2323
  • Manufacturer Parent Company (2017)
    Golden Technologies Inc
  • Source
    USFDA