Events

Recall of Synergy Pulse

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
    50144
  • Event Risk Class
    Class 2
  • Event Number
    Z-0600-2009
  • Event Initiated Date
    2008-10-09
  • Event Date Posted
    2009-01-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74813
  • 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
    Alternating Pressure Air Flotation Mattress - Product Code FNM
  • Reason
    These devices have the potential to overheat.
  • Action
    All end users (those who either purchased the device and any customer that has rented) were notified by an Urgent Field Safety Notice on/about 10/31/2008. The letter informed the customers of the safety risk and list steps they can take to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that were sold, the consignee of each device was notified by letter for the safety risk and what they can do to mitigate the risk until a Hill-Rom representative is able to modify the device. For the devices that are rented, an internal notification was sent via e-mail 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.

Device

Synergy Pulse
  • Model / Serial
    All serial numbers
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. || Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy.
  • 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