Z-0077-2011

DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The...

Name: Z-0077-2011 DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The...
Creator: Defibtech, LLC
Published: 2010-08-27
License: https://open.fda.gov/license/

Defibtech LLC / initiated 2010-08-27 / Terminated

FDA source

Defibtech, LLC began a recall of DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does... on 2010-08-27. The reason FDA records is "Data cards may include an incorrect format which may cause the AED to not function correctly". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0077-2011
Status: Terminated
Initiated: 2010-08-27
Posted: 2010-10-18
Terminated: 2011-10-05
Recalling firm: Defibtech LLC
Product: DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00 semiautomatic external defibrillator (AED). The DDC-6-AA data card is an accessory to the AED and does not have its own intended use.
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Data cards may include an incorrect format which may cause the AED to not function correctly.
FDA root cause: Mixed-up of materials/components
Action: Defibtech Initially notified customers by telephone on 8/27/10. Customers were notified of the product, the problem and the action to be taken. Customers were instructed to locate affected data cards and send them back to Defibtech for evaluation. If the data card was inserted into the AED, then the customer was instructed to check the AED software version. If the software version was at 2.005, the customer was instructed to keep the AED out of service until Defibtech could evaluate the returned data card. (Any other software version indicated that the device was not affected by a faulty data card). If the software version was any other version other than 2.005, then the customer was instructed to keep the AED in service unless the original service inquiry required it to remain out of service. If the data card was not inserted into the AED, then the customer was instructed to return the data card for evaluation. For any questions customers were to contact Customer Service at (866) 333-4241 from 8:30-5pm EST, M-F.
Quantity in commerce: 38
Distribution: USA - Nationwide Distribution and Puerto Rico
Product codes and lots: Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.

Product code MKJ

K013896Class IIISentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) Ddp-100; Battery Pack 1200Mah; BaDefibtech, LLC / cleared 2002-06-19

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)