Events

Recall of Permobil Chairman 2K powered wheelchair

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

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
    25733
  • Event Risk Class
    Class 2
  • Event Number
    Z-0834-03
  • Event Initiated Date
    2003-03-07
  • Event Date Posted
    2003-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26388
  • 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
    One of the wheelchair motors needed a grounding strap to ensure that the motors are at the same voltage potential as the chassis of the wheelchair.
  • Action
    Permobil Inc has notified its field representatives of the voluntary recall and these representatives have been provided with lists of each Chairman 2K serial number and the Dealer to which the wheelchair was sold. This list also includes the name of the individual for whom the wheelchair was specified at the time of order from Permobil Inc, where applicable. The Permobil field representatives have been trained to perform the upgrade and have been provided the necessary tools to complete the task. They will also train and supervise the Dealer''s technicians who will effect the upgrade at the Dealer level, as the field representatives will rely upon their Dealer network to complete the upgrades in a timely fashion.

Device

Permobil Chairman 2K powered wheelchair
  • Model / Serial
    Serial numbers: 1100155 to 1102472 and 4100019 through 4100225.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada and Puerto Rico
  • Product Description
    Permobil Chairman 2K powered wheelchair
  • Manufacturer
    Permobile Inc.

Manufacturer

Permobile Inc.
  • Manufacturer Address
    Permobile Inc., 6961 Eastgate Blvd, Lebanon TN 370906005
  • Source
    USFDA