FDA: Defibtech Lifeline and ReviveR Defibrillators Recalled

Defibrillators using software version 2.004 or earlier may cause the device to cancel shock

WEDNESDAY, May 11 (HealthDay News) -- Defibtech has issued a class I recall of Lifeline and ReviveR automated external defibrillators (AEDs), including model DDU-100 series with software version 2.004 or earlier, as AEDs using software version 2.004 or earlier may cause the device to cancel shock during the charging process.

The recall was issued because failure of an AED to work effectively may result in failure to resuscitate a patient. The recall involves 65,885 AEDs distributed in the United States.

Defibtech will provide customers with a free software upgrade. The company recommends that customers keep their AEDs in service during the software upgrade process since the conditions that may lead to a canceled shock rarely occur.

According to the U.S. Food and Drug Administration, "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."

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