Events

Recall of Magnum II Bariatric Patient Care System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom Manufacturing, 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
    28588
  • Event Risk Class
    Class 2
  • Event Number
    Z-0810-04
  • Event Initiated Date
    2004-03-04
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-05-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32177
  • 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
    Bed may pose a health hazard due to: a) inability to articulate the frame during transport, b) exposed sharp edge of footplate, c) shear point between seat section and lymph panel and d) patient fall.
  • Action
    Consignees were notified by letter via Federal Express on 3/9/2004.

Device

Magnum II Bariatric Patient Care System
  • Model / Serial
    Serial No. FTxxxxxx (where xxxxxx is a 6-digit number sequence)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The Magnum II Bariatric Patient System is primarily leased by hospitals, although some units have been sold Nationwide and Canada.
  • Product Description
    Magnum II Bariatric Patient Care System
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Manufacturer Address
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA