Z-0940-03

LIFEPAK CR Plus defibrillator

Name: Z-0940-03 LIFEPAK CR Plus defibrillator
Creator: Medtronic Physio Control Corp
Published: 2003-05-23
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2003-05-23 / Terminated

FDA source

Medtronic Physio Control Corp began a recall of LIFEPAK CR Plus defibrillator on 2003-05-23. The reason FDA records is "Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0940-03
Status: Terminated
Initiated: 2003-05-23
Posted: 2003-06-12
Terminated: 2004-02-24
Recalling firm: Physio Control, Inc.
Product: LIFEPAK CR Plus defibrillator
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Defibrillation therapy may be delayed or not delivered for persons needing defibrillation therapy.
FDA root cause: Other
Action: On 5/23/03, the firm issued a recall letter to customers advising of the malfunctions and instructions to check the device to assure it is ready for use. Service representatives will visit the customer sites and replace the flex circuit in all affected devices.
Quantity in commerce: 7095 devices
Distribution: The firm distributed units worldwide. Foreign distribution includes Australia, Canada, Costa Rica, Hong Kong, India, Israel, Jamaica, Netherlands, New Zealand, Saudi Arabia, South Africa, Uruguay.
Product codes and lots: All serial numbers below 31058753

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)