FDA Device recall Z-0175-2019
Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventric…
- FDA Device
- Class II
- terminated
- Published 2018-10-24
On 2018-10-24 the FDA classified a Class II recall of Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventric… by Philips Electronics North America, citing automated external defibrillators may not fully meet IPx5 water ingress specification. The device may fail to function should water intrusion occur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0175-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-10 |
| Published | 2018-10-24 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Electronics North America |
| Distribution | US |
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.
Identifiers
| code_info | Serial Numbers of affected AEDs begin with C16J, C16K, C17A, or C17B. Serial Numbers: C17B-00171 C17A-01227 C17A…Serial Numbers of affected AEDs begin with C16J, C16K, C17A, or C17B. Serial Numbers: C17B-00171 C17A-01227 C17A-01349 C17A-01361 C17B-00322 C17B-00323 C17B-00360 C17B-00172 C16K-01024 C17A-01356 C17A-01382 C17B-00038 C17A-01152 C16K-00726 C17A-01154 C17B-00101 C17B-00102 C17B-00104 C17B-00105 C17B-00107 C17B-00109 C17B-00110 C17B-00111 C17B-00112 C17B-00113 C17B-00114 C17B-00115 C17B-00116 C17B-00117 C17B-00118 C17B-00119 C17B-00125 C17B-00127 C17B-00132 C17B-00133 C17B-00143 C17B-00145 C17B-00158 C17B-00159 C17B-00160 C17B-00163 C16K-00495 C16K-00952 C16K-01029 C17B-00025 C17B-00057 C17B-00059 C17B-00069 C17B-00070 C17B-00071 C17B-00074 C17B-00077 C17B-00082 C17B-00083 C17B-00084 C17B-00089 C17B-00090 C17B-00098 C17B-00173 C17B-00178 C17B-00324 C17B-00120 C17B-00122 C17B-00123 C17B-00124 C17B-00126 C17B-00128 C17B-00129 C17B-00130 C17B-00131 C17B-00134 C17B-00135 C17B-00136 C17B-00137 C17B-00138 C17B-00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0175-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.