Events

Recall of Device Recall Invacare Pronto M41 Power 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
    68622
  • Event Risk Class
    Class 2
  • Event Number
    Z-2091-2014
  • Event Initiated Date
    2014-06-24
  • Event Date Posted
    2014-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128337
  • 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
    Invacare Pronto M41 Power Wheelchair - Product Code ITI
  • Reason
    M41 powered wheelchairs received through invacare service parts (isp) have controllers that were programmed in a way this is not aligned to standard factory settings. the controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control.
  • Action
    The controllers will be reporogrammed in the field upon installation Invacare Sent out a Technical Services Bulletin (Oct. 15, 2012) . Please call 800-832-4707, Monday-Friday, 8:00 am- 7:00 pm EST, for assistance. If you are aware of a consumer complaint regarding this controller, please contact the Invacare Customer Service Complaints Department at 877-374-8919, Monday-Friday, 8:00am- 7:00pm or cscomplaints@invacare.com

Device

Device Recall Invacare Pronto M41 Power Wheelchair
  • Model / Serial
    P/N 1143839
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distriution: CA, SC, IL, UT, TN, KS, HI, NJ, LA, TX,FL, IN, AL, AZ, MN, WI, MN, MI, AR,MA, GA, MS, NJ, NM, OK, ME, PA, NY, NC, OK, MO, WA, IA, OR,KY, MD, NE, ID, VA, WA, ND, MT, OH, NH, CT. Also shipped to Canada
  • Product Description
    MK5 NX Controller--Wheelchair controller
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation
  • Manufacturer Address
    Invacare Corporation, 1200 Taylor St, Elyria OH 44035-6248
  • Manufacturer Parent Company (2017)
    Invacare Corporation
  • Source
    USFDA