The Food and Drug Administration (FDA) of the United States posted a medical device safety alert concerning LIFEPAK CR Plus and LIFEPAK EXPRESS automated external defibrillators (AED), manufactured by Physio-Control Inc.
The affected AEDs may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position.
According to the manufacturer, a defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.
For details, please refer to the FDA Enforcement Report website:
http://www.accessdata.fda.gov/scripts/ires/index.cfm (Recall number: Z-2100-2016)
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 July 2016