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

Date of Recall

2004-11-10

Recall Details

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.

2. Potential of the AED to Turn on Unexpectedly:

The Company is aware of a situation involving certain of its AEDs in which the "ON/OFF" button of the device may become inoperative after the device turns on unexpectedly. The Company's investigation indicates to date that this failure mode is related to a specific manufacturer of a specific device component. To date, the Company has received 33 complaints of this occurrence in devices containing the component (representing a 0.3% complaint rate within the affected units), none of which have involved a patient treatment. If this potential problem occurs, the device may not defibrillate.

Although the investigation of this issue is still ongoing, the Company has determined that AEDs with the following serial numbers may have this problem: 075180 - 084760.

USERS ARE ADVISED TO IMMEDIATELY DISCONTINUE USE OF AND TO REMOVE FROM SERVICE ACCESS CARDIOSYSTEMS AED DEVICES WITH THE ABOVE REFERENCED CATALOG AND SERIAL NUMBERS: 075690 - 077140 OR 075180 - 084760.

The Company discontinued manufacturing and marketing ALL models of its AEDs and discontinued supporting its AEDs that are currently in service. The Company cannot accept orders for new AEDs, for consumable components (specifically disposable battery packs and electrode sets) used with its AEDs, and cannot service, repair or answer technical questions for existing AEDs.

For units not affected by the recall Access Cardiosystems is no longer accepting orders for disposable parts used with our AEDs. Therefore, when your supply of disposable parts is depleted, please immediately discontinue use of and remove from service all of the Company's AEDs that you have in your possession. Customers should consider replacing the AED's as soon as possible. It is your responsibility to equip yourself with AEDs that meet your medical needs.

Access CardioSystems, Inc. has notified affected customers on November 3, 2004 by registered mail return receipt requested mail. All interested parties with any questions should contact the Recall Coordinator at 1 978 405-1057.

In order to obtain the most updated information you may e-mail the Company at [email protected] or visit the Company's website at accesscardiosystems.com.

This recall is being conducted with the knowledge of the US Food & Drug Administration

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