Events

Recall of Device Recall KinAir MedSurg

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
    31207
  • Event Risk Class
    Class 2
  • Event Number
    Z-0583-05
  • Event Initiated Date
    2003-06-06
  • Event Date Posted
    2005-03-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37369
  • 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
    Weld failure causes side rail welds to turn upside down or break off of the bed.
  • Action
    The firm initiated the recall by telephone on 06/06/2003. The firm has inspected and corrected the beds.

Device

Device Recall KinAir MedSurg
  • Model / Serial
    Serial Numbers KASK00001 through KASK01212
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The beds were distributed nationwide and to Brazil.
  • Product Description
    KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
  • Manufacturer
    Kinetic Concepts, Inc

Manufacturer

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