Recall Z-0175-2019— Philips Electronics North America Corp.
Class II · Terminated
Class II FDA medical device recall by Philips Electronics North America Corp., initiated 2018-10-10, terminated 2022-08-19. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur..
- Recalling firm
- Philips Electronics North America Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-10-10
- Terminated
- 2022-08-19
- Firm location
- Bothell, WA, United States
Product description
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.
Reason for recall
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Data sourced from openFDA. This site is unofficial and independent of the FDA.