Physio-Control, Inc. a division of Medtronic, Inc. is notifying customers that some LIFEPAK 12 and LIFEPAK 20 defibrillator/monitors have a potential to incorrectly render a shock or no shock decision during automated external defibrillator (AED) analysis.  These defibrillators have specific sofware versions and must be set up with Auto Analyze ON for this issue occur.

Physio-Control, Inc. initiated a voluntary recall in January 2008 for LIFEPAK®  20 defibrillator/monitors manufactured from December 14, 2007 through December 18, 2007.  We determined that one of the Printed Circuit Board Assemblies did not meet all quality requirements and could eventually experience corrosion.       

This action was limited to 103 devices and was completed in January 2008.

Physio-Control, Inc, a division of Medtronic is conducting a voluntary recall for a single lot of  FASTPAK batteries used with a LIFEPAK 5, 10, 11 or 12 defibrillator/monitor that were mislabeled.  FASTPAK batteries lot code 0624 have a capacity of 1 amp/hour but were mislabeled as 2.4 amp/hour.       Reference TSU313

Physio-Control, Inc. a division of Medtronic is notifying customers who purchased a  LIFEPAK 1000 defibrillator installed with a specific component that could potentially cause the display to dim and eventually go blank. 

Physio-Control, Inc. a division of Medtronic is conducting a voluntary correction and notifying customers who have purchased Internal Paddles and Handles used with LIFEPAK®  9, LIFEPAK 9P, LIFEPAK 12, and LIFEPAK 20 defibrillator/monitor.  Recent retesting of sterilization methods requires that we modify our instructions for use and recommend changes to the sterilization methods listed in our current labeling.

Physio Control is conducting a correction for biphasic LIFEPAK ® 500 automated external defibrillator (AED) with software versions 4.4 or lower.          Reference TSU307            

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                                            

Physio-Control Inc., a division of Medtronic Inc., has identified that LIFEPAK CR Plus defibrillators manufactured from October 2002 through April 2004 with software version of 1.16 or lower can potentially miscalculate the internal battery capacity.       Reference TSU302