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LAWSUITS NEWS & LEGAL INFORMATION

Class 1 Recall Issued for LIFEPAK CR Plus Automated External Defibrillators


The FDA has 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. For a full list of the affected units see the link below.

This device is used by emergency or medical personnel, by others who have completed CPR AED training courses, or the public at large. It is intended to treat patients in cardiac arrest. The device analyzes an unconscious patient's heart rhythm and instructs the user to press a button that delivers an electrical shock to the heart to restore a normal heart rhythm.

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.

SEPT-16-09: FDA issues Class 1 Recall of LIFEPAK CR Plus Automated External Defibrillators [FDA: LIFEPACK CR PLUS CLASS 1 RECALL]

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Published on Sep-16-09


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