CLASS II Device recall · Reported 8 Apr 2020 · FDA Enforcement Report

LifePAK 500 Automated External Defibrillator recalled by Physio-Control

Physio-Control is recalling LifePAK 500 Automated External Defibrillator, distributed nationwide in the US. The recall was initiated on 20 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots

Quantity recalled173,459 units

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-1633-2020
FDA event ID: 85194
Recalling firm: Physio-Control, Redmond, WA
Classification: Class II
Status: Terminated
Recall initiated: 20 Mar 2020
FDA classified: 1 Apr 2020
Reported: 8 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Pacemakers & Defibrillators

Timeline

20 Mar 2020	Recall initiated by company
1 Apr 2020	Classified by FDA	+12 days
8 Apr 2020	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

Automated External Defibrillators may not detect a patient connection due to mechanical wear-through of the contact plating on the therapy connector. The wear-through could result in the device not recognizing a patient is connected which could result in a delay in treatment

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX - Product Usage: The LIFEPAK 500 AED is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient s electrocardiographic (ECG) rhythm and indicates whether it detects a shockable rhythm. The LIFEPAK 500 AED requires operator interaction to defibrillate the patient.

Where it was distributed

Worldwide distribution - US Nationwide distribution and countries of Afghanistan, American Samoa, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Cayman Islands, Chile, China, Columbia, Congo, Cook Islands, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Haiti, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Islamic Republic of, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lithuania, Macedonia, the former Yugoslav Republic of, Madagascar, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Province of China, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Bolivarian Republic of, Vietnam, Virgin Islands, British, Virgin Islands, U.S., Zimbabwe.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lots

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 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.

More recalls from Physio-Control

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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
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