ClearanceBrief
Recall Z-0294-04 ยท MKI

Medtronic Physio Control Corp

LIFEPAK 20 defibrillator/monitor. Paddle sets, an optional accessory item, used with the LP 20.

DateJan 6, 2004 (initiated Nov 12, 2003)
StatusTerminated
ReasonDevice unable to recognize the connection to the hard paddles accessory.
Root causeOther
ActionBeginning on 11/12/03 representatives from the firm visited the consignees and replaced the paddles. A letter dated November 2003 was provided to the consignees.
Quantity180 sets
DistributionThe firm distributed devices to 32 hospitals and medical centers located throughout the United States.
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