Defibtech recalls certain defibrillators

Defibtech

Defibtech LLC initiated a global recall for two of its semi-automatic external defibrillators.

The recall notice, which affects 65,885 AEDs distributed in the United States, applies to AEDs marketed under the Lifeline AED and ReviveR AED brands, the company said today.

The FDA classified the recall as Class I because it believes the products’ possible malfunction could cause serious injury or death.

The Guilford, Conn.-based company said the recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. Though failures are rare, the affected AEDs may cancel a life-saving shock during the device’s charging process, the company said. Defibtech also warned that conditions that cause the defect are not detectable by the AED’s periodic self test.

The company said its customers should keep their AEDs in service while the company sends out instructions on how to perform a corrective software upgrade.

This is the second recall in the last 12 months affecting the same products. In June 2010, the AED manufacturer initiated a voluntary recall of 5,418 DBP-2800 battery packs for the Lifeline AED and ReviveR AED products.

AEDs have fallen under more FDA scrutiny recently. The watchdog agency in November announced its External Defibrillator Improvement Initiative aimed at improving the safety and efficacy of automated external defibrillators. The federal watchdog agency said it’s received 28,000 reports of AED failures in the last five years, yet 300,000 Americans could benefit from treatment from the devices every year.

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