Date Recall Initiated: |
November 3, 2004 |
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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. |
Reason for Recall: |
One or both of the following problems may occur:
|
Public Contact: |
Access CardioSystems |
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 Access CardioSystems website at www.accesscardiosystems.com. Also, for additional information on this product recall, see the FDA Enforcement Report located at: http://www.fda.gov/bbs/topics/enforce/2004/ENF00876.html. Scroll down to "Recalls and Field Corrections: Devices - Class I". |
Updated March 7, 2005
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