Medical Device Safety and Recalls: Heart Sync, Multi-function Defibrillation Electrodes Will Not Work with Philips FR3 and FRx AEDs

A recall has been issued for Heart Sync, Multi-function Defibrillation Electrodes because they will not work with Philips FR3 and FRx AEDs.  Philips made changes to the connector design of their FR3 and FRx AEDs, and because of these changes, the Heart Sync electrodes will no longer work with these AEDs. The FRx AED requires electrode pads be connected to the device before it is used. The AED will make a continuous alarm chirp to alert the user that the correct pads are not connected. The FR3 does not require electrode pads to be pre-connected. Users will not know that the pads do not work until they try to use the AED. This may result in a delay in delivering the electrical therapy needed to revive a patient. Delay in therapy could result in serious injury or death.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm427974.htm


This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 Powered by GovDelivery