ClearanceBrief
Recall Z-0117-06 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)

Medtronic Emergency Response Systems, Inc.

standard (hard) paddles used with the LIFEPAK 12 defibrillator/monitor series.

DateNov 2, 2005 (initiated Sep 2, 2005)
StatusTerminated
ReasonPotential for voltage pins in connector of therapy cable to break.
Root causeOther
ActionOn 9/2/05 the firm issued letters dated September 2005 to their customers. The letters state the problem, advise the cables and/or connectors will be replaced, and emphasize daily inspection and testing,
DistributionDevices were distributed worldwide.
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