Events

Recall of Device Recall TotalCare SpO2RT 2 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
    64580
  • Event Risk Class
    Class 2
  • Event Number
    Z-0949-2013
  • Event Initiated Date
    2013-02-26
  • Event Date Posted
    2013-03-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116540
  • 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, flotation therapy, powered - Product Code IOQ
  • Reason
    In certain situations a software problem with the totalcare spo2rt¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. this may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. a correction to the software program is currently being developed and tested,.
  • Action
    Hill-Rom sent an Urgent Field Safey Notice letter dated February 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter advised customers to follow steps provided until the updated software is available. Customers were requested to forward a copy of this letter to any other facility personnel you deem appropriate. Questions should be directed to Hill-Rom Technical Support at 800-445-3720

Device

Device Recall TotalCare SpO2RT 2 bed
  • Model / Serial
    S/N between N230AM1358 & O023AM3687.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the state of Canada
  • Product Description
    TotalCare SpO2RT2 bed. || Product Usage: || Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT¿ 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Manufacturer Address
    Hill-Rom, Inc., 1069 State Route 46 East, Batesville IN 47006-7520
  • Manufacturer Parent Company (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA