Reported Oct 24, 2018 · Terminated
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat…
Philips Electronics North America Corp.
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: Philips Electronics North America Corp. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips HeartStart FR3 Defibrillator
- Model
861388861389
- Product UsageThe HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable pads applied to potential victims
- of SCA with the following symptoms1) Unresponsiveness 2) Absence of normal breathing The HeartStart FR3 is intended for adults and children over 55 pounds (25kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child s age or weight, do not delay treatment. Device not sterile and not implantable
- Lot codes and dates
- Serial Numbers of affected AEDs begin with C16J, C16K, C17A, or C17B
- Serial Numbers
432 of 432 codes
C17B-00171C17A-01227C17A-01349C17A-01361C17B-00322C17B-00323C17B-00360C17B-00172C16K-01024C17A-01356C17A-01382C17B-00038C17A-01152C16K-00726C17A-01154C17B-00101C17B-00102C17B-00104C17B-00105C17B-00107C17B-00109C17B-00110C17B-00111C17B-00112C17B-00113C17B-00114C17B-00115C17B-00116C17B-00117C17B-00118C17B-00119C17B-00125C17B-00127C17B-00132C17B-00133C17B-00143C17B-00145C17B-00158C17B-00159C17B-00160C17B-00163C16K-00495C16K-00952C16K-01029C17B-00025C17B-00057C17B-00059C17B-00069C17B-00070C17B-00071C17B-00074C17B-00077C17B-00082C17B-00083C17B-00084C17B-00089C17B-00090C17B-00098C17B-00173C17B-00178
- Amount recalled
- 432
Where it was sold
Why it was recalled
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
This product could cause temporary or reversible health problems — stop using it.
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