AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices

Notice type: Recall

Date: 15/11/2004


Product name or type:
AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices


Manufacturer Or Supplier:
Access CardioSystems Inc.

Target Audience:
Risk Managers; Medical Dental & Nursing Staff; Operating Theatres; Accident & Emergency; Intensive Care Units; Coronary Care Units; Medical Physics / EBME; Ambulance Staff & Paramedics; Resuscitation Officers; General Practitioners; Practice Nurses; Dental Practitioners

Problem Or Issue:
Recall of specified serial numbers of AccessAED PAD (model numbers 9100-0010-0 and 9100-0015-0), AccessAED (model numbers 9100-0100-0, 9100-0100-1, 9100-0150-0, and 9100-0150-1), and AccessALS (model numbers 9100-0100-2 and 9100-0150-2) automated external defibrillator devices and discontinued support by the manufacturer of all other devices that are in use.

Background Information Or Related Documents:

AccessAED PAD, AccessAED, and AccessALS automated external defibrillators may be in use in the hospital setting, GP practices, dental practices or the public domain.

The company has become aware of two potential issues involving specified serial numbers of automated external defibrillators (AED):

  • Potential failure of the shock delivery circuit.  This affects serial numbers 075690 – 077140
  • Potential of the AED to turn on unexpectedly.  This affects serial numbers 075180 – 084760  
The company has initiated a recall of all the above affected devices.   

Access CardioSystems has ceased trading since 03 November 2004 and has discontinued manufacturing and marketing of all models of AEDs.  They will no longer be in a position to support their AEDs that are currently in use on the market place.   

It should be noted that for all other Access CardioSystems AEDs not affected by the recall, orders for disposable parts used with the AEDs will no longer be accepted by Access CardioSystems.  The company advises customers that when the supply of disposable parts is depleted AEDs should be removed from service.

AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices Document

Actions To Be Taken:
  • Ensure that relevant all staff are advised of this Safety Notice.
  • Ensure that all specified serial numbers listed below are immediately removed from use:
    • AccessAED PAD, AccessAED, AccessALS, serial numbers 075180 – 084760
  • Replace all other AEDs, not specified in the scope of the recall, as soon as possible

Further Information:
All adverse incidents relating to a medical device should be reported to the:   

Medical Devices Department 
Health Products Regulatory Authority
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   

Telephone:     +353-1-6764971 
Fax:               +353-1-6344033 

Manufacturers website for updated information:     

Enquiries to the manufacturer should be addressed in the first instance to:   

Mr. John Webster 
Managing Director
MDCI Limited (European Authorised Representative for Access CardioSystems)   

Telephone:      +44-1293-429608 
Fax:                +44-1293-519121 

Enquiries to the distributors should be addressed to:   

Anaesthetic Services Limited 
85b Moss Road 
Co. Down BT23 6LF   

Telephone:      +44-2897-542995     

Genesys Medical Solutions Limited 
3 Wellington Park 
Malone Road 

Telephone:      +44-2890-923315 
Fax:                +44-2890-923334

Hibernia Medical Supplies
St. Pauls
North King St
Dublin 7

Telephone:      +353-1-6174862
Fax:                +353-1-6771558

SN2004(10): AccessAED PAD, AccessAED and AccessALS Automated External Defibrillator Devices

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