Announcements
Notice: FDA Issues Recall of
Medtronic LIFEPAK 500 AED
The FDA has issued a Class I recall of certain Medtronic LIFEPAK
500 automated external defibrillators (AEDs), due to the devices
continuing to display a \"connect electrodes\" message and may not
be analyzing the patient\'s cardiac rhythm even when the electrodes
are adequately and properly connected. This may cause healthcare
professionals not to defibrillate the patient even it
defibrillation is needed due to incorrect cardiac rhythm reading.
The FDA reports that the recall
affects 1,924 first-generation
LIFEPAK 500 AEDs that were manufactured in 1997. The FDA is clear
that the recall does NOT affect any other LIFEPAK 500 AEDs
currently produced, or any other LIFEPAK product. The
recalling
firm, Medtronic Emergency Response Systems Inc., has issued
notices to its customers regarding this issue, and will update or
upgrade customer devices at no charge by
March 31, 2005.
Recalled Products: LIFEPAK 500
automated external defibrillators
(AEDs), part numbers:
3005400-XXX
D3005400-XXX
U3005400-XXX.