|
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". |
|