Z-0710-06

LIFEPAK 12 defibrillator/monitor

Name: Z-0710-06 LIFEPAK 12 defibrillator/monitor
Creator: Medtronic Emergency Response Systems, Inc.
Published: 2006-03-22
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2006-03-22 / Terminated / root cause: manufacturing process

FDA source

Medtronic Emergency Response Systems, Inc. began a recall of LIFEPAK 12 defibrillator/monitor on 2006-03-22. The reason FDA records is "Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0710-06
Status: Terminated
Initiated: 2006-03-22
Posted: 2006-04-04
Terminated: 2011-09-06
Recalling firm: Physio Control, Inc.
Product: LIFEPAK 12 defibrillator/monitor
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Therapy connectors may have connector sockets that do not meet design specs - short drill depth. Interruption of the connections may cause unexpected, intermittent or complete loss of pacing and defibrillation functions.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 3/22/06, the firm began sending out letters dated March 2006, and flagged URGENT MEDICAL DEVICE CORRECTION. The letters advised customers of the issue and that a service representative would visit and inspect the therapy connector sockets, and replace the therapy connector and the mating cable if short drill sockets are found.
Quantity in commerce: 942 devices
Distribution: Nationwide, and Canada, Netherlands, Germany, Australia, Guam, Hong Kong, New Zealand, New Caledonia, Argentina, Brazil, Chile, Costa Rica, Mexico, Uruguay, Venezuela. Domestic distribution includes hospitals, clinics,
Product codes and lots: Domestic Serial Numbers: 34106383, 33996555, 33992033, 33992030, 33992029, 33992031, 33992027, 33990244, 33990241, 33990245, 33990242, 33990240, 34096406, 34086957, 34039438, 34100891, 33917921, 34100498, 34019560, 34011939, 34011940, 33985062, 33985063, 33985064, 33985065, 33985066, 33985067, 33985068, 33985070, 33985069, 33985074, 33985061, 33985071, 33985073, 33915256, 34016156, 34016153, 34016154, 34016155, 34016157, 34016158, 33989218, 33989220, 33989216, 33989219, 33989217, 34039448, 34048193, 34100900, 34020194, 34020192, 34060159, 33988136, 33988137, 34020193, 33995357, 33949669, 34074066, 33913884, 34014205, 11201950, 34091725, 34064561, 33913893, 33913894, 33913895, 34004873, 33995317, 33995318, 33995316, 33995315, 33995319, 34064439, 34064440, 34064441, 34020190, 34020507, 34020187, 34020189, 34020188, 34019563, 34019572, 34019573, 33904159, 33905092, 34095289, 34095297, 34095301, 33991999, 33992000, 33992003, 33992023, 33992028, 33992016, 33991998, 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Product code MKJ

K010918Class IIILifepak 12 Defibrillator/monitor SystemMedtronic Physio-Control Corp. / cleared 2001-08-23

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)