Events

Recall of Hill-Rom TotalCare SpO2RT pulmonary therapy bed system, Model 1900.

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
    31211
  • Event Risk Class
    Class 2
  • Event Number
    Z-0661-05
  • Event Initiated Date
    2005-03-01
  • Event Date Posted
    2005-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37384
  • 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
    Siderails may stay up without latching into place.
  • Action
    Consignees were notified via letter dated March 1, 2005 that Hill-Rom will contact them to coordinate a visit by Hill-Rom to upgrade affected beds.

Device

Hill-Rom TotalCare SpO2RT pulmonary therapy bed system, Model 1900.
  • Model / Serial
    All beds modified [to convert other beds to the TotalCare SpO2RT pulmonary therapy bed systems] with upgrade kits P1950A01 or P1950A02 between February 2002 and November 2004.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada.
  • Product Description
    Hill-Rom TotalCare SpO2RT pulmonary therapy bed system, Model 1900.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

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