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Philips Electronics North America Corp. recalls Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspe
Recalled October 24, 2018 · FDA recall Z-0175-2019 · Philips Electronics North America
Hazard
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur. · FDA Class II
Units
432
Sold at
Worldwide Distribution - U.S Nationwide in the states of: GA, MO, IN, FL, NY, HI, CA, LA, WA, IL, NE; Foreign (OUS):Australia, Austria,Belgium, Canada, France, Germany, Hong Kong, Italy, Japan, Kazakhstan, Netherlands, Norway, Spain, Switzerland, Taiwan, United Kingdom
Description
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Product
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The 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 symptoms: 1) 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.
Manufacturer(s)
Philips Electronics North America Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →