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U.S. Department of Health and Human Services

Medical Devices

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Defibtech LLC, Lifeline and ReviveR AEDs: Software Defect May Cancel Shock

Recall Class: Class I

Date Recall Initiated: March 14, 2011

Product: Model DDU-100 series with software version 2.004 or earlier, sold under the brand names Lifeline and ReviveR.

65,885 AEDs distributed in the United States are subject to this recall.

Defibtech will provide customers with a free software upgrade. Because the conditions that may lead to a canceled shock occur rarely, it is recommended that customers keep their AEDs in service during the software upgrade process. Full instructions and recommendations are being mailed to affected customers. Defibtech is responsible for contacting all end users unless a distributor has agreed to contact their accounts directly regarding this field correction.

Use: AEDs are used on victims of sudden cardiac arrest when the patient is unconscious, unresponsive and not breathing.

Recalling Firm:

Defibtech, LLC
741 Boston Post Road, Suite 201
Guilford, CT 06437-2714

Reason for Recall: AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process. Failure to provide appropriate therapy may result in failure to resuscitate the patient.

Public Contact: Questions may be directed to Al Raebuck, Customer Service Manager, Defibtech at techsupport@defibtech.com, 1-877-453-4507 or 1-203-453-4507.

FDA District: New England

FDA Comments:

Customers can check the nine-digit serial number on the back of their AED against the list published by Defibtech at http://www.defibtech.com/fa11 to see if their devices are affected.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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