Wednesday, September 16, 2009
Recall of LIFEPAK CR Plus Automated External Defibrillator (AED) due to defect that could result in delay or failure of treatment resulting in death
The FDA announced that Physio-Control, Inc. has issued an urgent Class I recall of a certain LIFEPAK CR Plus Automated External Defibrillator (AED) manufactured and distributed between July 9, 2008 through August 19, 2008, because the device may delay or fail to deliver therapy (shock) as a result of an improper analysis of the heart rhythm in an extremely humid environment resulting in severe complications or death. The device in question was manufactured and distributed between July 9, 2009 through August 19, 2009.
If you have any incidents or problems related to the use of this product you are encouraged to report the event or problem to the FDA's MedWatch Adverse Event Reporting program at 800.332.1088.
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