Events

Recall of Hill-Rom brand VersaCare Bed; Model P3200.

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
    29897
  • Event Risk Class
    Class 2
  • Event Number
    Z-1482-04
  • Event Initiated Date
    2004-08-24
  • Event Date Posted
    2004-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-01-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=34740
  • 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
    Pivot bolts on the sleep deck may become loose and fall out, allowing the head section to shift or to drop to one side, and a grounding warning label is missing.
  • Action
    Recall letters dated August 24, 2004 were sent to consignees advising them to inspect and monitor the beds until Hill-Rom can visit and make corrections.

Device

Hill-Rom brand VersaCare Bed; Model P3200.
  • Model / Serial
    All units.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Brazil, Canada, Hong Kong and United Arab Emirates.
  • Product Description
    Hill-Rom brand VersaCare Bed; Model P3200.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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