Events

Recall of Device Recall INDEPENDENCE iBOT 4000 Mobility System

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

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
    54643
  • Event Risk Class
    Class 2
  • Event Number
    Z-1775-2010
  • Event Initiated Date
    2010-02-22
  • Event Date Posted
    2010-06-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88873
  • 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
    Stair Climbing Wheelchair - Product Code IMK
  • Reason
    A thermal breaker in the battery pack has the potential to open due to overheating and disable one third of the cells in the affected battery pack.
  • Action
    The company sent Medical Device Field Correction letters to all customers on February 22, 2010 by certified mail.

Device

Device Recall INDEPENDENCE iBOT 4000 Mobility System
  • Model / Serial
    Serial Numbers 020605-001001 to 021007-001451 with Battery Pack(s) Revision 2.0. Serial number contains the month/year of manufacture followed by a sequential number.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to the United Kingdom.
  • Product Description
    iBOT 4000 Mobility System Battery pack.
  • Manufacturer
    Independence Technology LLC

Manufacturer

Independence Technology LLC
  • Manufacturer Address
    Independence Technology LLC, 45 Technology Dr, Warren NJ 07059-5148
  • Source
    USFDA