Audience: Emergency medical personnel, consumers
[Posted 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.
The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.
Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.
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].
[09/16/2009 - Recall Notice - FDA]
