Events

Recall of 3G Storm Series Power Wheelchair with Power Tilt Option.

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

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
    33772
  • Event Risk Class
    Class 2
  • Event Number
    Z-0303-06
  • Event Initiated Date
    2005-10-11
  • Event Date Posted
    2005-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42417
  • 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
    When the powered seating system is tilted completely in the rearward position, a potential pinch point is created between the seat and the seat frame.
  • Action
    The recalling firm sent letters to all consignees.

Device

3G Storm Series Power Wheelchair with Power Tilt Option.
  • Model / Serial
    Serial numbers: 05G066858, 05G066859, 05G071801, 05G071803, 05G077773, 05G079666, 05G089011, 05G089012, 05G092274, 05G105434, 05G106984, 05G111332, 05G117359, 05G121857, 05G125563, 05H144898
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was sent to distributors located in AL, GA, CA, IL, KS, MN, NC, PA, TX, and VA.
  • Product Description
    3G Storm Series Power Wheelchair with Power Tilt Option.
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, PO Box 4028, Elyria OH 44036-2028
  • Source
    USFDA