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
    36143
  • Event Risk Class
    Class 2
  • Event Number
    Z-0017-2007
  • Event Initiated Date
    2006-07-27
  • Event Date Posted
    2006-10-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48067
  • 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 FNL
  • Reason
    The patient pendant cord represents a potential trip hazard for the patient or the caregiver.
  • Action
    Consignees were notified via a letter dated 8/10/06 that included a package with installation instructions, materials and labels to modify the beds.

Device

Device Recall HillRom Versacare
  • Model / Serial
    All model P3200 VersaCare beds with the optional patient pendants P3207A01 or P3207A02.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Argentina, Australia, Brazil, Canada, China, Greece, Indonesia, Japan, Kuwait, Oman, Qatar, Thailand and United Arab Emirates.
  • Product Description
    Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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