Events

Recall of Device Recall HillRom VersaCare

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
    38256
  • Event Risk Class
    Class 2
  • Event Number
    Z-0240-2008
  • Event Initiated Date
    2006-11-12
  • Event Date Posted
    2007-07-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53251
  • 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
    Hospital Bed - Product Code FIN
  • Reason
    False latch/failure to latch-the side rail may not latch, or the latch may not fully engage, resulting in the siderail being able to be lowered without pulling on the release handle.
  • Action
    The firm notified consignees via an Urgent Device Correction letter dated 11/12/07 informing them of the problem and informed them they would be receiving upgrade kits which they could have their qualified personnel install themselves following video instructions also provided, or they could contact Hill-Rom for assistance.

Device

Device Recall HillRom VersaCare
  • Model / Serial
    Serial numbers E322AD0046 through H023AD6179. (E means 2003 production, F means 2004 production, G means 2005 production and H means 2006 production).
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Argentina, Australia, Brazil, Canada, Dominican Republic, Emirate of Sharjah, England, Greece, Indonesia, Japan, Jordan, Kuwait, Lebanon, Malaysia, Mexico, Oman, Pakistan, Philippines, Qatar, Saudi Arabia, Selangor, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arab Emirates and Venezuela.
  • Product Description
    Hill-Rom VersaCare Hospital Bed System; Models P3200 and P3201, Hill-Rom, Batesville, IN 47006
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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