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Lifeline AED DDU-100 semiautomatic external defibrillator… recallZ-1781-2010 · Defibtech LLC · initiated May 21, 2010

Terminated All recalls posted in June 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

The AED when used with an affected battery pack, may falsely detect an error condition, cancel charge and not provide therapy

FDA root cause category: Device Design

What the company is doing

Defibtech, LLC issued an "Urgent Medical Device Safety Information and Correction" notification dated May 20, 2010 by email and hard copy via US Mail. The notification instructed Consignees on proper identification of affected product and steps to take for product replacement. For further information, contact your distributor or Defibtech Technical Support at [email protected] or call 1-877-453-4507 or 1-203-453-4507, 8:30 AM to 5:00 PM Monday - Friday, EST.

Recall details

Recall number
Z-1781-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 21, 2010
Posted by the FDA
Jun 10, 2010
Recalling firm
Defibtech LLC
Product code
MKJ
FDA submissions
K013896
Distribution
Worldwide Distribution -- United States, Canada, Australia, Jordan, Spain, Israel, UK, Poland, Italy, Netherlands, Malaysia and Ireland.

Product description

Lifeline AED DDU-100 semiautomatic external defibrillator used with the DBP-2800 Battery Pack, Manufactured by Defibtech, LLC. Seymour, CT 06483. The DBP-2800 battery pack is an accessory to the AED and does not have its own intended use. The AED is intended for use on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.

Code information (models, lots, serial numbers)

Serial Numbers range from 202001005 through 202005916 and 206001001 through 206009871.

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.

Other products in the same recall event

The FDA groups related products into one recall event (event 55497).

Sources and updates

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