LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.
MedSun: Newsletter #48, May 2010

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of LIFEPAK 15 Monitor/Defibrillator manufactured and distributed between March 26, 2009 and December 15, 2009. There is a potential for the device to unexpectedly, power off then on by itself, power off then not turn on, power off by itself requiring the operator to turn it back on, or stay powered on and not allow itself to be turned off.

Additional Information:

FDA MedWatch Safety Alert. LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc. April 22, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm209467.htm


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