# FDA recall Z-1633-2020

> **Physio-Control, Inc.** · Class II · device recall initiated 2020-03-20.

## Product

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

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¿un

## Key facts

- **Recall number:** Z-1633-2020
- **Recalling firm:** Physio-Control, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-20
- **Report date:** 2020-04-08
- **Termination date:** 2024-01-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Redmond, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1633-2020

## Citation

> AI Analytics. FDA recall Z-1633-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1633-2020. Source: US FDA. Licensed CC0.

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