Events

Recall of Device Recall Sentry semi automatic external defibrillator (AED)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Defibtech, LLC.

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
    56729
  • Event Risk Class
    Class 2
  • Event Number
    Z-0077-2011
  • Event Initiated Date
    2010-08-27
  • Event Date Posted
    2010-10-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94386
  • 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
    Data cards may include an incorrect format which may cause the aed to not function correctly.
  • Action
    Defibtech Initially notified customers by telephone on 8/27/10. Customers were notified of the product, the problem and the action to be taken. Customers were instructed to locate affected data cards and send them back to Defibtech for evaluation. If the data card was inserted into the AED, then the customer was instructed to check the AED software version. If the software version was at 2.005, the customer was instructed to keep the AED out of service until Defibtech could evaluate the returned data card. (Any other software version indicated that the device was not affected by a faulty data card). If the software version was any other version other than 2.005, then the customer was instructed to keep the AED in service unless the original service inquiry required it to remain out of service. If the data card was not inserted into the AED, then the customer was instructed to return the data card for evaluation. For any questions customers were to contact Customer Service at (866) 333-4241 from 8:30-5pm EST, M-F.

Device

Device Recall Sentry semi automatic external defibrillator (AED)
  • Model / Serial
    Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    USA - Nationwide Distribution and Puerto Rico
  • Product Description
    DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). || The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
  • Manufacturer
    Defibtech, LLC

Manufacturer

Defibtech, LLC
  • Manufacturer Address
    Defibtech, LLC, 741 Boston Post Rd Ste 201, Guilford CT 06437-2714
  • Source
    USFDA