Z-0495-05

LIFEPAK 12 defibrillator/ monitors biphasic

Name: Z-0495-05 LIFEPAK 12 defibrillator/ monitors biphasic
Creator: Medtronic Emergency Response Systems, Inc.
Published: 2005-01-15
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2005-01-15 / Terminated / root cause: software

FDA source

Medtronic Emergency Response Systems, Inc. began a recall of LIFEPAK 12 defibrillator/ monitors biphasic on 2005-01-15. The reason FDA records is "The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0495-05
Status: Terminated
Initiated: 2005-01-15
Posted: 2005-02-03
Terminated: 2006-05-06
Recalling firm: Physio Control, Inc.
Product: LIFEPAK 12 defibrillator/ monitors biphasic
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.
Root cause tag: software
FDA root cause: Software design
Action: The firm sent 4000 User Notification letters via FED-EX on 1/15/2005 and approximately 3000 on 1/17/2005. The User Notification letters informed consignees about the two complaints and described the firm''s findings from their investigation into the problem. The letters also requested the users check the default energy settings; report back to the firm any discrepancies found; and reset the discrepant settings which differed from the user programmed settings.
Quantity in commerce: 28,835 devices distributed in the U.S.; 15,613 devices distributed internationally
Distribution: 28,835 devices were shipped to 6874 domestic consignees.
Product codes and lots: VLP12-02 Part Numbers all with a Biphasic label on the front of the device

Product code MKJ

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)