Events

Recall of Device Recall Pronto M51 Wheelchair

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
    35681
  • Event Risk Class
    Class 3
  • Event Number
    Z-1400-06
  • Event Initiated Date
    2006-06-14
  • Event Date Posted
    2006-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46610
  • 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 seat - Product Code ITI
  • Reason
    Some of the wheelchairs were distributed with seats that did not have a seat positioning strap.
  • Action
    The recalling firm sent a recall letter, dated 06/06 to consignees.

Device

Device Recall Pronto M51 Wheelchair
  • Model / Serial
    There is no code on the individual seat. Recall covers seats on wheelchairs distributed between 03/14/2006 and 04/07/2006.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Pronto M51 Wheelchair, component- seat
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1 Invacare Way, PO Box 4028, Elyria OH 44035
  • Source
    USFDA