Z-2010-2008

Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold...

Name: Z-2010-2008 Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold...
Creator: Physio Control, Inc.
Published: 2008-05-13
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2008-05-13 / Terminated / root cause: design

FDA source

Physio Control, Inc. began a recall of Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only on 2008-05-13. The reason FDA records is "A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2010-2008
Status: Terminated
Initiated: 2008-05-13
Posted: 2008-09-08
Terminated: 2011-03-20
Recalling firm: Physio Control, Inc.
Product: Physio-Control LIFEPAK 20e defibrillator/monitor. This product is an external defibrillator sold internationally only
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: A thicker keypad that may prevent the door from fully latching closed. If the door is not fully closed, there is a potential that the defibrillator will not automatically change from automatic external defibrillation (AED) mode to manual mode by pressing the "MANUAL" button located on the lower left corner of the door. This may lead to a delay in defibrillation therapy.
Root cause tag: design
FDA root cause: Device Design
Action: On 5/13/08, the firm sent out letters to their domestic customers via Certified Receipt. The letter advised customers of the recall and instructed them to do the following, "Keep the defibrillator in service. If pressing the MANUAL button does not take the defibrillator out of AED mode, press one of the following keys to select manual mode: "ENERGY SELECT", "CHARGE", "PACER", OR "LEAD"... Please call your local Physio-Control service representative to arrange a service visit to replace the keypads." If you have questions, contact Technical Support at 1-800-442-1142, option 5.
Quantity in commerce: 24 units
Distribution: Product distributed to 1 US embassy, 97 domestic medical facilities nationwide, and 5 foreign consignees including the following countries: Germany, Netherlands, Canada, Australia and Hong Kong.
Product codes and lots: Keypad lot codes (Lot codes appear on the original product packaging, but are not stamped onto the keypads): 10-07, 11-07, 12-07-P093, 12-07-P094, 01-08-N116, 01-08-N126, 01-08-P091, 01-08-P093. Device Part Number: 3202488-053; Device SN: 36053634, 36053641, 36053642, 36053647, 36053651, 36053653, 36053654, 36082047, 36082048, 36082049, 36082050, 36082051, 36082054, 36102742, 36102743, 36102744, 36102745, 36102746, 36107743, 36107744, 36107746, 36107747, 36109647, and 36109667

Product code LDD

K063119Class IIILifepak 20 Defibrillator/ MonitorMedtronic Emergency Response Systems, Inc. / cleared 2006-12-22

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)