Events

Recall of Device Recall Advanta bed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom, 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
    28420
  • Event Risk Class
    Class 2
  • Event Number
    Z-0726-04
  • Event Initiated Date
    2004-03-08
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-09-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31809
  • 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
    A potential pinch/shear point exists between the restraint strap hook located underneath the knee section and the foot rail mounting of the bed.
  • Action
    A recall letter dated March 8, 2004 was sent to each consignee advising them of the problem, and that Hill-Rom will visit the facility to modify the beds.

Device

Device Recall Advanta bed
  • Model / Serial
    All units distributed between January 1, 2004 and February 11, 2004.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    California, Delaware, Idaho, Indiana, Massachusetts, Michigan, Mississippi, New York, North Carolina, Ohio, South Dakota, Tennesee and Canada.
  • Product Description
    Hill Rom brand Advanta bed; model P1600.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 125 E Pearl St, Batesville IN 47006
  • Source
    USFDA