Events

Recall of Device Recall Access Cardiosystems

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

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
    30378
  • Event Risk Class
    Class 1
  • Event Number
    Z-0206-05
  • Event Initiated Date
    2004-11-03
  • Event Date Posted
    2004-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35860
  • 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
    Device may fail to deliver shock due to a faulty circuit board.
  • Action
    AccessCardiosystems issued recall letters on 11/3/04 to US Customers by Registered, Certified, Return Receipt requested USPS mail. The foreign mailings made through Federal Express with delivery confirmation.

Device

Device Recall Access Cardiosystems
  • Model / Serial
    Serial Numbers: 075180 through 084760
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore
  • Product Description
    AccessAED PAD Package (without ECG trace) || Model Number: 9100-0015-0
  • Manufacturer
    Access CardioSystems

Manufacturer

Access CardioSystems
  • Manufacturer Address
    Access CardioSystems, 150 Baker Avenue Ext Ste 108, Concord MA 01742-2196
  • Source
    USFDA