Events

Recall of Device Recall Powerheart AED G3

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardiac Science, 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
    30704
  • Event Risk Class
    Class 2
  • Event Number
    Z-0400-05
  • Event Initiated Date
    2004-11-12
  • Event Date Posted
    2005-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-06-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36661
  • 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
    Automated External Defibrillators (Non-Wearable) - Product Code MKJ
  • Reason
    Aeds may contain an electronic component that does not meet its full operating specifications. the aeds with this suspect electronic component may not functionn properly and may interfere with the aed's ability to delivery therapy. in the event that charge noise is presrent it will delay the first defibrillation shock in the 3 shock sequence.
  • Action
    Cardiac Science will contact customers via telephone to set up a time for Clinical Educator to visit the customer and conduct a field test on each AED. AEDs that fail the field test will be replaced either on the spot or within 24 hours. AEDs failing the test are either removed by the Clinical Educator or are returned to Cardiac Science upon receiving the new AED. Cardiac Science anticipates testing to be done by the end of December 2004.

Device

Device Recall Powerheart AED G3
  • Model / Serial
    Model no. 9300P serial numbers: 900290 thru 900870
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Throughout the United States, Canada and Europe.
  • Product Description
    Powerheart AED G3 Automated External Defibrillator Model 9300P Professional series). Cardiac Science AEDs are manufactured by: Manufacturing: Cardiac Science, Inc., 5474 Feltl Road, Minnetonka, MN 55343-7982.
  • Manufacturer
    Cardiac Science, Inc.

Manufacturer

Cardiac Science, Inc.
  • Manufacturer Address
    Cardiac Science, Inc., 5474 Feltl Rd, Minnetonka MN 55343-7982
  • Source
    USFDA