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Defibitech, LLC, has issued a worldwide product recall of its Lifeline AED and ReviveR AEDTM defibrillators. This recall affects all ReviveR and Lifeline AEDs (automatic external defibrillators) with software versions 2.002 and older.
The Defect
The self-testing software for these defibrillators may allow a self-test to wipe out the product's memory of a previously detected low battery condition. If this occurs, the device may fail to notify the operator of the low battery, which could in turn cause the defibrillator to fail to deliver a shock when necessary.
Defibitech has received three reports of malfunctions from its users.
This FDA has determined that this is a Class 1 Recall, which is the most serious designation given to recalls of devices that can potentially cause serious injury or death if their problems goe uncorrected.
The Recall
Defibitech has sent notification letters of the recall to its distributors and customers.
There have been about 42,000 of these affected units distributed worldwide to schools, health clubs, businesses, fire & EMS, and hospitality companies. The affected units are identified by the words “Lifeline AED” and “ReviveR AEDTM” appearing on the front of the device.
The company has also sent out a notification of the proper maintenance procedure that can be used to verify that the device is functional until the upgraded software is installed.
Included with the maintenance procedure is a procedure that will allow you to determine which version of the software is installed on each defibrillator.
Harmed by a Defective Product?
If you or a loved one has been seriously injured as a result of the malfunction of a Defibitech defibrillator or any other defective product, please contact us today for a complimentary consultation with an experienced and competent product liability attorney who will examine your case thoroughly and determine if you are eligible to seek compensation for your losses. We may be able to help you recover damages including medical bills, pain, suffering and more.