Recall Z-0077-2011 ยท MKJ Automated External Defibrillators (Non-Wearable)
Defibtech, LLC
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.
| Date | Oct 18, 2010 (initiated Aug 27, 2010) |
| Status | Terminated |
| Reason | Data cards may include an incorrect format which may cause the AED to not function correctly. |
| 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 dat |
| Quantity | 38 |
| Distribution | USA - Nationwide Distribution and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013896 | SENTRY SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR; EXTERNAL DEFIBRILLATION PADS (ELECTRODES) DDP-100; BATTERY PACK 1200MAH; BA Defibtech, LLC, Jun 19, 2002 |