Events

Recall of Device Recall Envision E700 Low Airloss Therapy Surface

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hill-Rom Manufacturing, 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
    49490
  • Event Risk Class
    Class 2
  • Event Number
    Z-0088-2009
  • Event Initiated Date
    2008-06-19
  • Event Date Posted
    2008-10-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73614
  • 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
    Powered Flotation Therapy Bed - Product Code IOQ
  • Reason
    A defect in the software of the device may not allow the patient bed exam alarm or the patient movement alarm to function correctly.
  • Action
    An internal Modification Notice dated 9/1/08 was sent via email to Service Centers (because the device is owned by the manufacturer, Hill-Rom, each Service Center in possession of the device will be the consignee). Each Service Center will perform the correction on the units affected. Each device in the affected serial number range will be tested for the software defect. If the defect is found, the circuit board that contains the defective software will be replaced. The Field Action Plan is expected to be completed on July 24, 2008. Expected completion date of the Correction will be 12 months from July, 2008.

Device

Device Recall Envision E700 Low Airloss Therapy Surface
  • Model / Serial
    Serial numbers DB100527 thru DB101305.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and country of Canada.
  • Product Description
    Envision E700 Low Airloss Therapy Surface, Made By Hill-Rom Manufacturing, Inc., Charleston, SC. || The Envision E700 Low Airloss Therapy Surface helps prevent and treat stage III and stage IV pressure ulcers in patients who weigh between 70 lb and 400 lb and are between 4'11" and 6' 4" in height.
  • Manufacturer
    Hill-Rom Manufacturing, Inc.

Manufacturer

Hill-Rom Manufacturing, Inc.
  • Manufacturer Address
    Hill-Rom Manufacturing, Inc., 4349 Corporate Rd, Charleston SC 29405-7445
  • Source
    USFDA