Recall of Device Recall KCI Therapulse II

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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, Air Fluidized - Product Code INX
  • Reason
    Battery outgassing of powered hospital beds.
  • Action
    The firm initiated the recall via letter on 03/22/2004.


  • Model / Serial
    Serial numbers: TPLK00053, TPLK00052, TPLK00011, TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
  • Product Description
    KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
  • Manufacturer


  • Manufacturer Address
    Kinetic Concepts, Inc, 4958 Stout Dr, San Antonio TX 78219-4334
  • Source