Reported Mar 26, 2014 · Terminated
Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a…
Philips Medical Systems North America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems North America Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. 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 defibrillator pads applied to potential victims
- of SCA with the following symptoms-Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) 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
- Lot codes and dates
- Serial
- numbers of units distributed in the USA
128 of 128 codes
C13A-00592C13C-00131C13C-00150C13C-00270C13C-00679C13C-00681C13C-00769C13D-00048C13D-00197C13E-00088C13E-00168C13E-00234C13E-00242C13E-00245C13E-00326C13E-00340C13E-00368C13E-00372C13E-00380C13E-00382C13E-00390C13E-00406C13E-00495C13E-00507C13E-00511C13E-00516C13E-00526C13E-00537C13F-00011C13F-00012C13F-00013C13F-00022C13F-00024C13F-00027C13F-00031C13F-00032C13F-00033C13F-00035C13F-00038C13F-00043C13F-00047C13F-00053C13F-00054C13F-00059C13F-00071C13F-00077C13F-00078C13F-00102C13F-00104C13F-00110C13F-00114C13F-00118C13F-00126C13F-00131C13F-00137C13F-00138C13F-00140C13F-00143C13F-00146C13F-00148
- Serial numbers of units outside the USA
123 of 123 codes
C13C-00004C13C-00256C13C-00305C13C-00323C13C-00608C13C-00639C13E-00009C13E-00021C13E-00036C13E-00048C13E-00057C13E-00058C13E-00065C13E-00163C13E-00250C13E-00265C13E-00273C13E-00311C13E-00323C13E-00328C13E-00339C13E-00341C13E-00345C13E-00346C13E-00349C13E-00350C13E-00351C13E-00358C13E-00393C13E-00395C13E-00404C13E-00407C13E-00409C13E-00424C13E-00437C13E-00441C13E-00452C13E-00454C13E-00455C13E-00499C13E-00503C13E-00518C13E-00527C13E-00535C13E-00548C13F-00010C13F-00280C13F-00286C13F-00293C13F-00298C13F-00302C13F-00303C13F-00305C13F-00306C13F-00316C13F-00317C13F-00343C13F-00345C13F-00346C13F-00358
- Amount recalled
- 251 units total (128 in USA and 123 untils outside USA)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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