(Note: Click here for the AED Recall from March 11, 2009)
A Class 1 Recall has been announced by the FDA for LifePak CR Plus Automated External Defibrillators (AEDs) made by Physio Control, Inc.
The recalled LifePak defibrillators are used to deliver electric shocks to a patients’ heart in order to restore a normal heart rhythm. These units have a voice prompt that instructs the healthcare professional to “press the shock button”. However, the shock button on this AED is covered and not visible. Thus responders unable to follow the instructions and administer the shock.
For more information please contact Physio Control, Inc. at 425-867-4000, extension 4644.
It’s a shame that Medtronic/Physio-Control can’t get their act together. We represent all brands of AEDs and there is no solution other than complete replacement for those that not only are faced with recalled units, but the discontinuation of the LIfepak 500.
Also, when the FDA halted their shipping twenty (20) months ago, it’s always been the response of customer service that they would be shipping in 3 months. They are not doing any service to their existing customers or distributors. It’s a shame.
Assume this is on device set to deliver shock automatically after analysis is performed. Assume this is an option on a unit so if you take option shock button stickered over and if you do not button visible and voice commands handle appropriately. Is this what problem is?