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Terminated

LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic defibrillation operation. It has the ability to externally pace, manually defibrillate, or automatically analyze and if necessary, defibrillate a patient through therapy cables with disposable electrodes, standard paddles, or internal handle cables. Product is labeled with ''Medtronic Physio-Control, Redmond, WA''

FDA Recall Z-0542-03 · Posted 2003-02-05

Recalling FirmMedtronic Physio Control Corp
Recall StatusTerminated
Product CodeMKJ
Date Initiated2003-01-27
Date Terminated2004-02-24
Product Quantitydomestic: 30,575 foreign: 15,467

Reason for Recall

Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit.

Firm Action

Consignees were notified of recall action by letter dated January 2003. Letter advised consignees to follow recommendations for periodic inspections and to test device to verify readiness. A few weeks later the consignees were sent a correction letter along with user installable shields.

Root Cause

Other

Distribution Pattern

Worldwide distribution, including government/military accounts.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K010918LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMMedtronic Physio-Control Corp. · 2001-08-23K002445LIFEPAK 12DEFIBERLLATOR/MONITOR SERIESMedtronic Physio-Control Corp. · 2001-01-31K991910LIFEPAK 12 BIPHASICPhysio-Control Corp. · 1999-09-03K990338NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEMPhysio-Control Corp. · 1999-09-01K973486LIFE PAK 12Physio-Control Corp. · 1998-01-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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