Events

Recall of BariMaxx II bariatric bed

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
    33679
  • Event Risk Class
    Class 2
  • Event Number
    Z-0129-06
  • Event Initiated Date
    2004-08-16
  • Event Date Posted
    2005-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42270
  • 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, Ac-Powered Adjustable Hospital - Product Code FNL
  • Reason
    Design change to uppgrade reliability of powered adjustable bed.
  • Action
    All consignees were notified with a technical bulletin explaining the inspection and addition of washers to the set-screws.

Device

BariMaxx II bariatric bed
  • Model / Serial
    Product Code 80 FNL, BariMaxx II Serial numbers: BKOk00006 through BKOK00100
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Bari Maxx II, KCI''s BariMaxx II bariatric bed, P/N 310611, November 2001, KCI The Clinical Advantage, P. O. Box 659508, San Antonio, Texas 78265-9508, Call Toll Free 1-800-531-5346, FAX (210) 308-3998, Http://www.kci1.com
  • Manufacturer
    Kinetic Concepts, Inc

Manufacturer

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