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U.S. Department of Health and Human Services

Medical Devices

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Certain Medtronic LIFEPAK 500 Automated External Defibrillators

Class 1 Recall
Date Recall
Initiated:
February 3, 2005
Product:
LIFEPAK 500 automated external defibrillators (AEDs), part numbers 3005400-XXX, D3005400-XXX and U3005400-XXX. This action affects 1,924 devices. All were manufactured in 1997.
Use:
Automated external defibrillators are intended to be used for the treatment of cardiac arrest. The defibrillators are intended to deliver a shock to the heart to restore normal heart rhythm. Prior to delivering the shock, the device analyzes the patient’s heart rhythm to determine if a shock is appropriate. These devices are used by first responders such as firefighters, police and others trained in CPR and AED use.
Recalling Firm:
Medtronic Emergency Response Systems, Inc.
11811 Willows Road, NE
Redmond, WA 98052-2003
Reason for Recall:
The affected AEDs may display a "Connect Electrodes" message and then will not defibrillate the patient, even when the electrodes are properly connected.
Public Contact:
Customers with further questions about this issue should call 1-877-873-7630 to determine if their device is included in the action.
FDA District:
Seattle
FDA Comment:

Medtronic distributed notices via certified mail on February 3, 2005 to customers who purchased these types of AEDs. The company will update or upgrade customer devices at no charge by March 31, 2005. We recommend that the defibrillators remain in service when no alternative is available until they can be replaced. Customers are currently being contacted with recommendations for use and replacement schedules.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.