Z-0761-2017Class II

The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor...

Name: Z-0761-2017 The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor...
Creator: Physio-Control, Inc.
Published: 2010-03-11
License: https://open.fda.gov/license/

Physio Control, Inc. / initiated 2010-03-11 / Terminated / root cause: manufacturing process

FDA source

Physio-Control, Inc. began a recall of The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental... on 2010-03-11. FDA classified it as Class II and gives the reason as "Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation...". 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-0761-2017
Classification: Class II
Status: Terminated
Initiated: 2010-03-11
Posted: 2016-12-14
Terminated: 2016-12-16
Recalling firm: Physio Control, Inc.
Product: The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. Product Part Numbers V-15-2-000XXX
Product code: MKJ Automated External Defibrillators (Non-Wearable)
Reason for recall: Customer complaint was received relating to a LifePak15 device that would power on then power down unexpectedly after a short period of use. When the LP15 powered down, power could be immediately restored by activation of the power button. The device was connected to a cellular modem from MultiTech systems for use with LIFE NET services. The corrective action was completed by Velocitor Solutions in December 2010.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: Velocitor initiated this field action and notified affected customers on March 11, 2010. This action was reported to Physio-Control as completed on 12/21/2010.
Quantity in commerce: 1399 units (866 in the US and 533 outside US)
Distribution: worldwide
Product codes and lots: This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0761-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0761-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code MKJ

K082937Class IIILifepak 15 Monitor/defibrillatorPhysio-Control, Inc. / cleared 2009-03-11

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)