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Biphasic LIFEPAK® 12 Defibrillator/Monitor
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Physio-Control, Inc., a division of Medtronic, Inc. is voluntarily conducting a 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. If this occurs, it may result 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 |
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Internal Defibrillation Paddles and Handles Without Discharge Control
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Physio-Control, a division of Medtronic Inc., is notifying customers who have purchased internal defibrillation paddles and handles without discharge control (i.e., hands free internal paddles requiring a defibrillation adapter) for use with LIFEPAK® 9 or LIFEPAK 9P defibrillator / monitors. Recent retesting of sterilization methods can no longer support existing guidelines. We are advising customers to discontinue use of these accessory items and remove them from service. In the U.S. call our Technical Support number at 1-800-442-1142 to discuss available replacement options. In other countries, please call your local representative. Select Resource Link for additional information to help identify these accessory items. |
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LIFEPAK® 20 defibrillator/monitor
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Physio-Control, a division of Medtronic, Inc. is notifying customers of a Safety Alert where customers have attempted to use the LIFEPAK 20 defibrillator/monitor without first disconnecting the QUIK-COMBO® test plug. Failure to disconnect the test plug and reconnect the QUIK-COMBO electrodes could delay or prevent therapy to a patient. |
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External Sterilizable Defibrillation Paddles
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| Physio-Control is notifying customers who have purchased External Sterilizable Defibrillation Paddles and Pediatric Paddle attachments used with LIFEPAK® 9 / 9P, LIFEPAK 12 and LIFEPAK 20 / 20e defibrillator / monitors regarding a modification to the cleaning and sterilization instructions. Recent internal review of sterilization methods requires that we modify the operating instructions for these accessories and recommend changes to the sterilization methods listed in our current labeling. - TSU 328 |
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LIFEPAK® CR PLUS and LIFEPAK EXPRESS® defibrillator
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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 |
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LIFEPAK® 12 and LIFEPAK 20 defibrillator/monitor
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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. Reference TSU 317 / 318 |
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Biphasic LIFEPAK® 500 AED
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Physio Control is conducting a correction for biphasic LIFEPAK ® 500 automated external defibrillator (AED) with software versions 4.4 or lower. Reference TSU307 |
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LIFEPAK CR® Plus/LIFEPAK EXPRESS® defibrillator
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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 |
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LIFEPAK CR® Plus defibrillator
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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 |
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