Lifeline and ReviveR Defibrillator Recall
Defibtech, LLC recalled certain DDU-100 series semi-automatic external defibrillators (AEDs) sold under the Lifeline AED and ReviveR AED brand names, including 65,885 AEDs distributed in the United States.
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This recall affects only DDU-100 Series AEDs shipped with 2.004 software or earlier. This corrective action addresses two possible conditions that may cause an affected AED to cancel shock during the charging process and not provide therapy. If this happens the defibrillator may fail to resuscitate the patient.
- Condition 1: In rare instances, the AED may cancel charge in preparation for a shock.
- Condition 2: In rare instances, the AED may cancel charge in preparation for a shock in very high humidity conditions.
A subset of AEDs (less than 11%) that are affected by Condition 1 are also affected by Condition 2.
The AEDs affected by this recall have been distributed globally to fire departments, EMS, health clubs, schools, and other organizations. The Food and Drug Administration (FDA) has determined that this action is a Class I recall.
Any adverse reactions experienced with the use of this product and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800- FDA-1088, or on the MedWatch website at www.fda.gov/medwatch. In addition, you should contact an attorney for a free consultation. It is important that you do not do anything to destroy evidence or in any way adversely affect your legal rights.
