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U.S. Department of Health and Human Services

Class 2 Device Recall Sentry semi automatic external defibrillator (AED)

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  Class 2 Device Recall Sentry semi automatic external defibrillator (AED) see related information
Date Initiated by Firm August 27, 2010
Date Posted October 18, 2010
Recall Status1 Terminated 3 on October 05, 2011
Recall Number Z-0077-2011
Recall Event ID 56729
510(K)Number K013896  
Product Classification Automated external defibrillators (non-wearable) - Product Code MKJ
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.
Code Information Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.
Recalling Firm/
Manufacturer		 Defibtech, LLC
741 Boston Post Rd Ste 201
Guilford CT 06437-2714
For Additional Information Contact Al Raebuck
203-453-6654 Ext. 122
Manufacturer Reason
for Recall		 Data cards may include an incorrect format which may cause the AED to not function correctly.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MKJ and Original Applicant = DEFIBTECH, LLC
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