medical Class II Updated 2020-04-08

Physio-Control, Inc. recalls LifePAK 500 Automated External Defibrillator, model numbers:

Recalled 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.


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All Lots
View official government recall

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