ClearanceBrief
Recall Z-0938-04 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

Medtronic Physio Control Corp

LIFEPAK 12 defibrillator/monitor.

DateJul 20, 2004 (initiated Apr 5, 2004)
StatusTerminated
ReasonPotential for display to go blank due to an electrical component that may fail due to mechanical shock of vibration of the defibrillator.
Root causeOther
ActionLetters dated April 2004 were sent to customers on 4/6/04. The letter explains that a service representative will visit the customer and check the capacitor.
Quantity2885
DistributionDevices were distributed to hospitals and medical centers throughout the US. The firm also distributed units internationally.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012274MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
Medtronic Physio-Control Corp., Feb 5, 2002