Events

Recall of Device Recall Permobil Chairman 2K powered wheelchair, Model 1280

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
    25692
  • Event Risk Class
    Class 2
  • Event Number
    Z-0671-03
  • Event Initiated Date
    2003-01-01
  • Event Date Posted
    2003-03-21
  • 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=26284
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    unknown device name - Product Code I--TI
  • Reason
    Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.
  • 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.

Device

Device Recall Permobil Chairman 2K powered wheelchair, Model 1280
  • Model / Serial
    Serial Numbers: 1100068 to 1103702
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Puerto Rico, Canada
  • Product Description
    Permobil Chairman 2K powered wheelchair, Model 1280
  • Manufacturer
    Permobile Inc.

Manufacturer

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