Physio-Control Recalls LIFEPAK CR Plus AEDs
The Food and Drug Administration is notifying health care 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.
For more complete information, view the recall notice here.
Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's online MedWatch Adverse Event Reporting program, by phone at 1-800-332-1088, or by returning the postage-paid FDA Form 3500 by mail or fax at 1-800-FDA-0178.