Reported Apr 8, 2020 · Terminated
LifePAK 500 Automated External Defibrillator, model numbers: 3005400-XXX, U3005400-XXX, 3011790-XXX/, U3011790-XXX -…
Physio-Control, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Physio-Control, Inc. · 11811 Willows Rd Ne · Redmond, WA · 98052-2003
Is this the product you have?
- LifePAK 500 Automated External Defibrillator
- model numbers
3005400-XXXU3005400-XXX3011790-XXX/
- U3011790-XXX - Product UsageThe 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
- Lot codes and dates
- All Lots
- Amount recalled
- 173,459 units
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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