Z-0548-06

LIFEPAK EXPRESS defibrillator

Name: Z-0548-06 LIFEPAK EXPRESS defibrillator
Creator: Medtronic Emergency Response Systems, Inc.
Published: 2006-01-31
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2006-01-31 / Terminated / root cause: manufacturing process

FDA source

Medtronic Emergency Response Systems, Inc. began a recall of LIFEPAK EXPRESS defibrillator on 2006-01-31. The reason FDA records is "One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative". 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-0548-06
Status: Terminated
Initiated: 2006-01-31
Posted: 2006-02-23
Terminated: 2011-01-17
Recalling firm: Physio Control, Inc.
Product: LIFEPAK EXPRESS defibrillator
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: One of the printed circuit board assemblies may be contaminated with solder flux which can cause a short that may render the device inoperative.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 1/31/06 the firm sent a letter flagged URGENT-MEDICAL DEVICE RECALL to their customers via certified return receipt. The letter advised customers of the problem and requested the customers inspect their units at least weekly. The customers are provided additional guidance if they see certain symbols as described in the letter. The firm''s service personnel will visit the customers, remove and replace units.
Quantity in commerce: 20,525 devices total - CR Plus and LIFEPAK Express
Distribution: Units were distributed worldwide to public access environments.
Product codes and lots: Part number 3202177-00 through -002 Serial numbers listed above with the CR Plus

Product code MKJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)