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Philips Electronics North America Corp.: Medical Device Recalls in 2018

Updated on March 25, 2026.

According to to data from the FDA, there were 3 medical device recalls made by Philips Electronics North America Corp. in 2018. See the details of the recalls below.

You can see similar recalls for other firms.

Data Source: FDA.
See this for other years:
2018
  • Philips HeartStart FRx AED.
  • Philips HeartStart (HS1) Onsite/Home AED
  • 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.
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