Z-1050-2008

Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part...

Name: Z-1050-2008 Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part...
Creator: Physio Control, Inc.
Published: 2008-01-08
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2008-01-08 / Terminated / root cause: manufacturing process

FDA source

Physio Control, Inc. began a recall of Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036... on 2008-01-08. The reason FDA records is "Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA)". 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-1050-2008
Status: Terminated
Initiated: 2008-01-08
Posted: 2008-03-29
Terminated: 2013-09-04
Recalling firm: Physio Control, Inc.
Product: Physio-Control LIFEPAK 20 defibrillator/monitor, AC powered external defibrillator with battery backup. Part Numbers: 3202487-073, 3202487-079, 3202488-036, Physio Control, Inc, Redmond, WA 98052
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Inoperable Device - Potential for delay in therapy or prevention of defibrillation therapy due to corrosion of the Printed Circuit Board Assemblies (PCBA).
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm contacted Customers by phone and by Urgent-Medical Device Recall letters sent via return receipt requested to their consignees on 1/8/08. The letter advised consignees that the Printed Circuit Board Assemblies (PCBA) might not meet quality requirements. This manufacturing deviation could lead to eventual PCBA corrosion that could render the device inoperative and not ready for use in an emergency under battery power. The firm recommended keeping the unit in service until it could be replaced. Representatives will visit each consignee and replace units.
Quantity in commerce: 103 total devices - 84 domestic, 19 international
Distribution: Worldwide Distribution --- USA including states of OK, SC, TX, and WA, and country of Germany.
Product codes and lots: Serial Numbers (domestic units): 36133753, 36133760, 36139018, 36139023, 36139030, 36137448, 36138998, 36141356, 36141357, 36141358, 36141360, 36141361, 36141362, 36141363, 36141365, 36141366, 36141367, 36141370, 36141373, 36141378, 36141380, 36141381, 36141382, 36141383, 36141384, 36141393, 36141394, 36141395, 36141396, 36141399, 36141400, 36142717, 36142718, 36142730, 36142731, 36141386, 36141398, 36133739, 36133740, 36133742, 36133743, 36133744, 36133745, 36133746, 36133747, 36133748, 36133749, 36133750, 36133751, 36133752, 36133754, 36133755, 36133756, 36133757, 36133758, 36133759, 36137218, 36137219, 36137220, 36137222, 36137224, 36137225, 36137226, 36137227, 36137230, 36137231, 36137352, 36137353, 36137355, 36137356, 36137357, 36137359, 36137360, 36137361, 36137362, 36137363, 36137364, 36137365, 36137366, 36137367, 36137368, 36137369, 36139002, 36139010 Serial Numbers (international units): 36137354, 36137358, 36137370, 36137371, 36137372, 36138999, 36139000, 36139005, 36139006, 36139007, 36139009, 36139011, 36139012, 36139013, 36139014, 36139021, 36139024, 36139025, 36139031

Product code MKJ

K012274Class IIMedtronic Physio-Control Lifepak 20 Defibrillator/monitor/pacemakerMedtronic Physio-Control Corp. / cleared 2002-02-05

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)