Philips HeartStart FR3 Defibrillator — Class II medical device recall Z-0175-2019
Terminated recall by Philips Electronics North America Corp., reported 2018-10-24, distributed nationwide. Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to
| Recall number | Z-0175-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Philips Electronics North America Corp., Bothell, WA, United States |
| Recall initiated | 2018-10-10 |
| Classified | 2018-10-17 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2022-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, DE, ES, FR, GB, HK, IT, JP, NL, NO, TW |
| Quantity | 432 |
| Reason classes | device malfunction |
| Serial numbers | C16J-01286, C16K-00495, C16K-00497, C16K-00726, C16K-00790, C16K-00903, C16K-00944, C16K-00952, C16K-01024, C16K-01029, C17A-00426, C17A-00831, C17A-00833, C17A-00834, C17A-00835, C17A-00837, C17A-00838, C17A-00839, C17A-00840, C17A-00841, C17A-00842, C17A-00843, C17A-00844, C17A-00845, C17A-00846 and 407 more |
| Model numbers | 861388, 861389 |
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 for recall
Automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.