Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
LifePAK 500 Automated External Defibrillator Recalled by Physio-Control, Inc. Due to Automated External Defibrillators may not detect a patient...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Physio-Control, Inc. directly.
Affected Products
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.
Quantity: 173,459 units
Why Was This Recalled?
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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Physio-Control, Inc.
Physio-Control, Inc. has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report