The U.S. Food and Drug Administration (FDA) has
issued a class 1 recall of the LIFEPAK 20 and LIFEPAK 20e external
defibrillator/monitors, which are designed for use
by trained medical personnel in hospitals and clinic settings to
monitor patient heart rhythms and to treat patients experiencing
cardiac arrest. The recall affects approximately 43,000 devices
distributed worldwide over a five-year period starting in September 2002. The
reason for the recall is a failure in the power-supply assembly that results in
"No DC power" or "No DC or AC power." A malfunction of
battery power can result in a failure to deliver defibrillation therapy if the
device does not turn on using DC power and if no AC power is available.
Failures of the AC or DC power supply can be
detected during routine daily checks. Customers are advised to keep the defibrillators in service and follow
recommended daily Operator Checklist steps while service updates are
scheduled. Physio-Control Technical Support may be reached at rs.sealifepaksupport-usa@medtronic.com or call 1-800-442-1142, Monday – Friday between 6:00 A.M. and 4:00 P.M. (Pacific Time).