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DDC-6-AA Data Card, an accessory to the Sentry DDU-1 00… recallZ-0077-2011 · Defibtech, LLC · initiated Aug 27, 2010

Terminated All recalls posted in October 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Defibtech, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Mixed-up of materials/components

What the company is doing

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.

Recall details

Recall number
Z-0077-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 27, 2010
Posted by the FDA
Oct 18, 2010
Recalling firm
Defibtech, LLC
Quantity
38
Product code
MKJ
FDA submissions
K013896
Distribution
USA - Nationwide Distribution and Puerto Rico

Product 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.

Code information (models, lots, serial numbers)

Data cards are not serialized. Data cards are traced by shipment dates from July 19, 2010 through August 25, 2010.

Other devices under the same FDA submission

10 devices cleared under K013896 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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