HeartSine recalls SAM 350P, 360P, and 500P defibrillators that may have incorrect language settings, risking delayed or no life-saving shocks during cardiac emergencies.
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
HeartSine is recalling its Samaritan PAD defibrillators (SAM 350P, 360P, 500P) because they might have incorrect language configurations. This could delay or prevent life-saving therapy during a cardiac emergency, making it critical to check your device.
The defibrillators may have been distributed with the wrong language settings. This could cause the device to delay or skip delivering a life-saving shock when needed during a cardiac emergency, potentially worsening the situation.
People who own or use HeartSine Samaritan PAD defibrillators (SAM 350P, 360P, or 500P) are affected. Those with the devices in their home or emergency kit are most at risk if they need to use them during a cardiac event.
Check for the model numbers SAM 350P, SAM 360P, or SAM 500P on your device. The serial numbers listed in the recall include specific combinations like SAM 350P/05060167120671/17D00006810 or SAM 360P/5060167127120.
Look for the model number on your defibrillator (SAM 350P, SAM 360P, or SAM 500P) and compare it to the list of serial numbers provided in the recall.
No, the recall does not require immediate stoppage. You can continue using it but should check the model and serial numbers to see if it is affected.
The recall does not specify a remedy, so you should contact HeartSine directly for further instructions.
The recall does not provide details on how to check language settings, so you should contact HeartSine for help.
We’ve drafted a message you can send HeartSine to request your refund or repair — edit it as you like.
Subject: Recall Z-1217-2023 — HeartSine HeartSine Hello, I own a HeartSine that is covered by recall Z-1217-2023 from HeartSine. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
