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November 12, 2004

Access Cardiosystems, Inc. Issues a Worldwide Recall of Automated External Defibrillators (AED'S)

Topics: Clinical Pharmacology

FDA Report.
Contact: Recall Coordinator, 1-978-405-1057

FOR IMMEDIATE RELEASE --Concord, MA-- Nov. 10, 2004 -- Access CardioSystems,   Inc., Concord, Massachusetts, initiated a voluntary recall of all of its Automated   External Defibrillators (AED's). Additionally, for reasons beyond its control,   the Company is no longer doing business.

We have identified two potential problems with certain AED's that warrant your   immediate attention:

1. Potential Failure of the Shock Delivery Circuit:

The Company is aware of a situation involving certain of its AEDs in which   the device may experience a catastrophic failure of the shock delivery circuit.   The Company's investigation indicates to date that this failure mode is restricted   to a specific batch of one device component. To date, the company has received   11 complaints of this occurrence in devices containing the component shown to   be associated with this failure mode (representing a 0.8% complaint rate within   the affected units). When this potential problem occurs, it is not possible   to deliver additional defibrillation shocks.

Although the investigation of this issue is still ongoing, the Company has   determined that AEDs with the following serial numbers may have this problem:   075690 - 077140.

Posted by Hyscience at November 12, 2004 12:33 AM



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