Events

Recall of Device Recall Eagle Parts and Products

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Eagle Parts and Products.

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
    36213
  • Event Risk Class
    Class 2
  • Event Number
    Z-0039-2007
  • Event Initiated Date
    2006-07-11
  • Event Date Posted
    2006-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48197
  • 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
    Power Wheel Chairs - Product Code ITI
  • Reason
    The wheel hub bolts may loosen resulting in the wheels coming off.
  • Action
    Consignees were first notified by letter on 07/11/2006. Recall was expanded to include all units on 07/28/2006.

Device

Device Recall Eagle Parts and Products
  • Model / Serial
    Serial numbers 624EZ0010 through 624EZ0513.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, FL, GA, KY, NC, SC TN, TX
  • Product Description
    Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motors.
  • Manufacturer
    Eagle Parts and Products

Manufacturer

Eagle Parts and Products
  • Manufacturer Address
    Eagle Parts and Products, 1411 Marvin Griffin Rd, Augusta GA 30906-3852
  • Source
    USFDA