FDA Recall Terminated

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.

Recall: Z-0077-2011 · Initiated August 27, 2010

Recall

Recall Number
Z-0077-2011
Event Number
56729
Firm
Defibtech, LLC
FEI Number
3003521780
Product Code
MKJ
Status
Terminated
Root Cause
Mixed-up of materials/components
Initiated
August 27, 2010
Posted
October 18, 2010
Terminated
October 5, 2011
Address
741 Boston Post Rd, Ste 201, Guilford, CT, 06437-2714

Description

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.

Reason

Data cards may include an incorrect format which may cause the AED to not function correctly.

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.

Distribution

USA - Nationwide Distribution and Puerto Rico

Quantity

38