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

FDA device recall Z-0077-2011 · posted 2010-10-18 · Terminated

Recall details

Recalling firm

Defibtech, LLC

Reason for recall

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

Action taken

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.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

MKJ

Quantity affected

38

Distribution

USA - Nationwide Distribution and Puerto Rico

Date initiated

2010-08-27

Date posted

2010-10-18

Date terminated

2011-10-05

Location

Guilford, CT

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