CLASS I Device recall · Reported 15 Mar 2017 · FDA Enforcement Report

The Lifepak 1000 defibrillator is intended recalled by Physio-Control

Physio-Control is recalling The Lifepak 1000 defibrillator is intended for use by personnel who are authorized by a, distributed nationwide in the US. The recall was initiated on 13 Jan 2017 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAffected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.

Quantity recalledtotal 133,330 units (50,046 units in the 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-1257-2017
FDA event ID: 76252
Recalling firm: Physio-Control, Redmond, WA
Classification: Class I
Status: Terminated
Recall initiated: 13 Jan 2017
FDA classified: 3 Mar 2017
Reported: 15 Mar 2017
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

13 Jan 2017	Recall initiated by company
3 Mar 2017	Classified by FDA	+49 days
15 Mar 2017	Published in enforcement report	+12 days

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

Reason for recall

The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

Product as listed by the FDA

The LIFEPAK 1000 defibrillator is intended for use by personnel who are authorized by a physician/medical director and are trained in CPR and the use of the LIFEPAK 1000 defibrillator.

Where it was distributed

Worldwide Distribution - US (nationwide) and in the following countries: Bahrain, Belize, Cambodia, Chile, China, C¿te d'Ivoire, Ecuador, Germany, Honduras, Hong Kong, India, Indonesia, Jamaica, Myanmar, Netherlands, Niger, Philippines, Saudi Arabia, Senegal, Singapore, Sri Lanka, Thailand, Tunisia, Ukraine, and Zambia.

Nationwide

Questions about this recall

Is The Lifepak 1000 defibrillator is intended for use by personnel who are authorized by a recalled?

Yes. Physio-Control recalled The Lifepak 1000 defibrillator is intended for use by personnel who are authorized by a on 13 Jan 2017. The recall is Class I and its status is Terminated. Recall number Z-1257-2017.

Why was it recalled?

The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.

Which lots are affected?

Affected Product Part Numbers: 320371500XX. There are 133,330 affected serial numbers.

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Physio-Control

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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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