CLASS II Device recall · Reported 21 Dec 2016 · FDA Enforcement Report

The Lifepak 15 monitor/defibrillator is intended recalled

Physio-Control is recalling The Lifepak 15 monitor/defibrillator is intended for use by trained medical personnel in. The recall was initiated on 11 Mar 2010 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesThis action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.

Quantity recalled1399 units (866 in the US and 533 outside US)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0761-2017
FDA event ID: 75743
Recalling firm: Physio-Control, Redmond, WA
Classification: Class II
Status: Terminated
Recall initiated: 11 Mar 2010
FDA classified: 14 Dec 2016
Reported: 21 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

11 Mar 2010	Recall initiated by company
14 Dec 2016	Classified by FDA	+2470 days
21 Dec 2016	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

worldwide

Questions about this recall

Why was it recalled?

Which lots are affected?

This action was taken by Velocitor Solutions to notify their customers in 2010. The consignee list was not provided to Physio-Control.

Where was it sold?

worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS II	Lifepak 15, REF: 99577-000025, 99577 recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
18 Mar 2026Device	CLASS II	Physio Control Infant/Child Reduced Energy Defibrillator Electrodes recalled	Physio-Control	Other	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 1000 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak 15 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide
10 Sep 2025Device	CLASS II	Lifepak CR2 Part recalled by Physio-Control	Physio-Control	Processing Deviation	Nationwide

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