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LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-X...

FDA Device Recall #Z-1633-2020 — Class II — March 20, 2020

Recall Summary

Recall Number Z-1633-2020
Classification Class II — Moderate risk
Date Initiated March 20, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Physio-Control, Inc.
Location Redmond, WA
Product Type Devices
Quantity 173,459 units

Product Description

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.

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

Distribution Pattern

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.

Lot / Code Information

All Lots

Other Recalls from Physio-Control, Inc.

Recall # Classification Product Date
Z-1544-2026 Class II PHYSIO CONTROL INFANT/CHILD Reduced Energy Defi... Jan 21, 2026
Z-2498-2025 Class II LIFEPAK 1000 Part / Catalog Numbers / UDI-DI co... Jul 22, 2025
Z-2497-2025 Class II LIFEPAK 15 Part / Catalog Numbers / UDI-DI code... Jul 22, 2025
Z-2499-2025 Class II LIFEPAK CR2 Part / Catalog Numbers / UDI-DI co... Jul 22, 2025
Z-1232-2025 Class II LIFEPAK 20e REF 99507-000001 The AED mode is... Feb 3, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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