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U.S. Department of Health and Human Services

Medical Devices

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Access CardioSystems Automated External Defibrillators

Class I Recall
Date Recall
Initiated:
November 3, 2004
Product:
Access CardioSystems, Inc. Automated External Defibrillators (AEDs), serial numbers 075690 to 077140 or 075180 to 084760. Approximately 10,000 devices are in distribution.
Use:
Automated external defibrillators are intended to be used for the treatment of cardiac arrest. The defibrillators are intended to deliver a shock to the heart to restore normal heart rhythm. These devices are used by hospitals, fire departments and emergency medical services personnel.
Recalling Firm:
Access CardioSystems, Inc.
150 Baker Avenue
Concord, MA 01742-2196
Reason for Recall:

One or both of the following problems may occur:

  • the defibrillator may fail to deliver a shock due to a faulty circuit board
  • the defibrillator may turn on unexpectedly causing the “on/off” switch to become inoperative making the device unable to defibrillate.
Public Contact:
Access CardioSystems
(978) 405-1057
FDA District:
New England
FDA Comment:

Customers should immediately stop using the recalled devices. Additionally, the firm has discontinued supporting all of its AEDs and no longer accepting orders for any disposable parts. Customers are advised to replace their Access CardioSystems AEDs as soon as possible.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

  For additional information on this product recall, see the FDA Enforcement Report.