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     Product Notices

LIFEPAK® 15 Monitor/Defibrillator

Physio-Control, Inc. is initiating a voluntary correction for a limited number of LIFEPAK monitor / defibrillators due to a component that may inadvertently contact  the power printed circuit board assembly.  Should this occur, we have verified that the monitor / defibrillator may:

    • cycle power Off, then On by itself
    • power Off by itself requiring the operator to turn it pack On
    • stay powered on and not allow itself to be powered Off 

Select the "Resources" Link to download a copy of the notification.   Select  "Serial Numbers" to search for specific serial numbers affected by this action.



Biphasic LIFEPAK® 12 Defibrillator/Monitor

Physio-Control, Inc., a division of Medtronic, Inc.  has completed a voluntarily correction to specific Biphasic LIFEPAK 12 defibrillator/monitors manufactured with a printed circuit board assembly that contain a component with excess solder which could cause an intermittant short  resulting in no therapy delivery or delivery of an incorrect defibrillation waveform.  There have been no reported failures or complaints due to this potential issue.   -  TSU 332

FDA classified this action on February 22, 2010 as Class II.     Physio-Control has completed this action for all units that could be located.     Please use "Resources" link to see March 2009 customer notification.



LIFEPAK® CR PLUS and LIFEPAK EXPRESS® defibrillator

Physio-Control, Inc. a division of Medtronic is notifying customers of a voluntary recall for LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators (AEDs) manufactured between November 2006 and March 2008.  These AEDs contain a specific internal flex cable that may be susceptible to failure and could potentially short, preventing the AED from powering on. - Reference TSU326                                                                                  



Biphasic LIFEPAK® 500 AED

Physio Control is conducting a Follow-Up notification to our correction for biphasic LIFEPAK ® 500 automated external defibrillator (AED) with software versions 4.4 or lower.          Reference TSU307          Customers who have not upgraded their identified LIFEPAK 500 AEDs or who have not confimed they have reset their Energy Protocol are receiving final notification letters.

       Please select  "Resources" link to download  Fixed Sequence Energy Protocol Instuctions   



LIFEPAK CR® Plus/LIFEPAK EXPRESS® defibrillator

REVISED - Physio-Control, Inc., a division of Medtronic Inc., is recalling specific LIFEPAK CR® Plus and/or a LIFEPAK EXPRESS® defibrillators manufactured from December 2005 through August 2006.     Please refer to new August 2007 letter.                                                Reference TSU303                                            



LIFEPAK CR® Plus defibrillator

Physio-Control is conducting a Final follow-up notification to our correction for LIFEPAK CR Plus defibrillators manufactured from October 2002 through April 2004 with software version of 1.16 or lower that can potentially miscalculate the internal battery capacity.          Reference TSU302  -  Customers who have not confirmed they have upgraded their units are receiving final notification letters.    To determine if unit is affected, select  "Search Affected" link.        To determine if your unit has been upgraded, select "Resources".



 

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