Z-0837-2007

LIFEPAK EXPRESS defibrillator

Name: Z-0837-2007 LIFEPAK EXPRESS defibrillator
Creator: Medtronic Emergency Response Systems, Inc.
Published: 2006-10-05
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2006-10-05 / Terminated / root cause: manufacturing process

FDA source

Medtronic Emergency Response Systems, Inc. began a recall of LIFEPAK EXPRESS defibrillator on 2006-10-05. The reason FDA records is "Premature battery depletion due to electrical component failure". 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-0837-2007
Status: Terminated
Initiated: 2006-10-05
Posted: 2007-06-21
Terminated: 2013-08-08
Recalling firm: Physio Control, Inc.
Product: LIFEPAK EXPRESS defibrillator
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Premature battery depletion due to electrical component failure
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a regular basis, inspect their defibrillator(s) per the LIFEPAK CR Plus/EXPRESS Operating Instructions - Section 5 Caring for the Defibrillator. The letter also provides a website to allow consignees to enter their device serial number(s) to determine if their LIFEPAK CR Plus/LIFEPAK EXPRESS are included in the action. This recall strategy is subject to modification pending the performance of devices remaining on the market.
Quantity in commerce: Total of Express 1,006 units worldwide; amount does not include units distributed to Japan.
Distribution: Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.
Product codes and lots: Serial Numbers are for units with lead free capacitor C177. The following list of Serial Numbers does not include units sent to Japan, as firm does not consider them to be part of its Safety Alert action. 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Product code MKJ

K011144Class IIILifepak 600 Automated External DefibrillatorMedtronic Physio-Control Corp. / cleared 2001-12-03

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)