Z-0203-05

AccessALS (Advanced Life Support) Model Number: 9100-0100-2

Name: Z-0203-05 AccessALS (Advanced Life Support) Model Number: 9100-0100-2
Creator: Access CardioSystems
Published: 2004-11-03
License: https://open.fda.gov/license/

Access Cardiosystems, Inc. / initiated 2004-11-03 / Terminated

FDA source

Access CardioSystems began a recall of AccessALS (Advanced Life Support) Model Number: 9100-0100-2 on 2004-11-03. The reason FDA records is "Device may fail to deliver shock due to a faulty circuit board". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0203-05
Status: Terminated
Initiated: 2004-11-03
Posted: 2004-11-20
Terminated: 2006-04-12
Recalling firm: Access Cardiosystems, Inc.
Product: AccessALS (Advanced Life Support) Model Number: 9100-0100-2
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Device may fail to deliver shock due to a faulty circuit board
FDA root cause: Other
Action: AccessCardiosystems issued recall letters on 11/3/04 to US Customers by Registered, Certified, Return Receipt requested USPS mail. The foreign mailings made through Federal Express with delivery confirmation.
Quantity in commerce: 382 units
Distribution: Nationwide Foreign: Spain, Ireland, Chile, Beirut, India, Israel, Singapore
Product codes and lots: Serial Numbers: 075180 through 084760

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)