Z-0542-03

LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system...

Name: Z-0542-03 LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system...
Creator: Medtronic Physio Control Corp
Published: 2003-01-27
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2003-01-27 / Terminated

FDA source

Medtronic Physio Control Corp began a recall of LIFEPAK 12 defibrillator/monitor is a portable, battery operated, complete acute cardiac care response system with both manual and semi-automatic... on 2003-01-27. The reason FDA records is "Impact and damage to the high voltage connectors results in poor or no electrical contact from the cable to the LIFEPAK 12 unit". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0542-03
Status: Terminated
Initiated: 2003-01-27
Posted: 2003-02-05
Terminated: 2004-02-24
Recalling firm: Physio Control, Inc.
Product: 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''
Product code: MKJ Automated External Defibrillators (Non-Wearable)
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.
FDA root cause: Other
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.
Quantity in commerce: domestic: 30,575 foreign: 15,467
Distribution: Worldwide distribution, including government/military accounts.
Product codes and lots: Each unit is given a unique serial number. All LIFEPAK 12 units are affected.

Product code MKJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)