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FDA MedWatch

LIFEPAK CR Plus AEDs: Class I recall due to failure or delay in delivery of therapy/shock

LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)

Audience: Emergency medical personnel, consumers

09/16/2009 - FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].

Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm182496.htm

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
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