Recall of LIFEPAK CR Plus Automated External Defibrillators

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09/17/09
The American Nurses Association (ANA) provides the following important recall information received from the FDA:

The FDA notified healthcare professionals (09/16/09) 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 downloading and returning the postage-paid FDA Form 3500 [pdf] by mail or fax [1-800-FDA-0178].

[Read 09/16/2009 FDA Recall Notice ]

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