Events

Recall of Kinetic Concepts

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Kinetic Concepts, 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
    25452
  • Event Risk Class
    Class 2
  • Event Number
    Z-0748-03
  • Event Initiated Date
    2000-04-11
  • Event Date Posted
    2003-04-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25853
  • 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
    Bed, Flotation Therapy, Powered - Product Code IOQ
  • Reason
    Battery failure/ outgassing.
  • Action
    Service centers were notified of the new battery maintenance policy on 4/11/2000 in a Technical Bulletin and again on 9/11/2000. Non-service center customers were notified by letter in October 2002.

Device

Kinetic Concepts

Manufacturer

Kinetic Concepts, Inc
  • Manufacturer Address
    Kinetic Concepts, Inc, 4958 Stout Drive, San Antonio TX 78219
  • Source
    USFDA