Events

Recall of Life Pulse High Frequency Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bunnell, 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
    57377
  • Event Risk Class
    Class 2
  • Event Number
    Z-0901-2011
  • Event Initiated Date
    2010-10-25
  • Event Date Posted
    2011-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96003
  • 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
    High Frequency Ventilator - Product Code LSZ
  • Reason
    Product software coding error may compromise patient safety.
  • Action
    Customers were notified by an "Urgent: Medical Device Recall or Correction" letter starting 10/22/10. The letter identified the product and described the issues. Customers were given the option of either returning their ventilator(s) for rework or to receive installation/re-test instructions with an upgrade kit to rework themselves. The letter states that all Life Pulse ventilators in clinical use must be upgraded and there is no charge for the software upgrade.

Device

Life Pulse High Frequency Ventilator
  • Model / Serial
    Model 203A
  • Product Classification
    Anesthesiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, Czech Republic, Korea, Malaysia, Trinidad & Tobago, and Uruguay.
  • Product Description
    One Cat. Life Pulse High Frequency Ventilator, Catalog Number: 203A, Manufactured by: Bunnell Incorporated Salt Lake City, Utah, Rx Only.
  • Manufacturer
    Bunnell, Inc.

Manufacturer

Bunnell, Inc.
  • Manufacturer Address
    Bunnell, Inc., 436 Lawndale Dr, Salt Lake City UT 84115-2917
  • Source
    USFDA