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Access CardioSystems Inc. Recalls AccessAED and AccessALS, Ceases Operations

By J. M. Hendry

November 2004, MERGINET—Access CardioSystems Inc. initiated a

voluntary recall of the AccessAED and AccessALS external defibrillator devices.

The Concord, Massachusetts-based company no longer supports or provides parts

for the company’s previously sold AEDs, and it also ceased manufacturing.

The U.S. Food and Drug Administration (FDA) announced the recall on

November 10, 2004, but purchasers of the firm’s AEDs received notification via

a November 3 registered letter.

The recall affects the following units:

AccessAED and AccessALS units - catalog number 9100-0100 and serial numbers

075690-077140 - due to 11 complaints of “a catastrophic failure of the shock

delivery circuit.â€

AccessAED, AccessALS units - catalog number 9100-0100 and serial numbers

075180-084760 - due to 33 complaints “in which the ‘ON/OFF’ button of the

device may become inoperative after the device turns on unexpectedly.â€

Customers should “immediately discontinue use of and remove from

service†the above referenced devices, the recall states. Affected customers

can obtain additional information by calling the Recall Coordinator at

1-978-405-1057, or by e-mail to recall@....

Access CardioSystems Inc. no longer accepts orders for disposable

AED parts for units not affected by the recall, and suggests immediate

discontinuation of all the company’s AEDs once the “supply of disposable

parts is depleted.†Access CardioSystems Inc. will no longer supply parts,

service, repair or technical assistance for existing AED units, or accept

orders for new AEDs.

It is the customer’s responsibility, the recall notice states,

“to equip yourself with AEDs that meet your medical needs.â€

Regards,

steve

Stevan Pierce, WEMT-Paramedic

Remote Support Paramedic

A.C.E. Personal Trainer

Health, Safety and Fitness Specialist

ermedicsp@...

" some say a hero could save us, I'm not going to stand here and wait "

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