Events

Recall of Device Recall Pronto Series 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
    32009
  • Event Risk Class
    Class 2
  • Event Number
    Z-0902-05
  • Event Initiated Date
    2005-05-02
  • Event Date Posted
    2005-06-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-01-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38923
  • 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
    If the arm of the wheelchair is overloaded, the joystick mounting brackett and/or arm pivot may fail due to variability in the plastic used by the supplier to make the components. this failure may cause the user or a caregiver to fall if they are leaning on the arm, and result in injury.
  • Action
    The recalling firm contacted all consignees by phone between May 9 and May 25, 2005 and sent an urgent field correction needed letter, dated April, 2005 to all consignees.

Device

Device Recall Pronto Series Power Wheelchair.
  • Model / Serial
    All serial numbers between 05A000-05C999.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was sent to consignees located in AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. There was one foreign consignee in France: Poirer, Zac Papillon, 3720 Parcay Meslay, Corps, France
  • Product Description
    Pronto Series Power Wheelchair, model M61.
  • Manufacturer
    Invacare Corporation

Manufacturer

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