HeartSine recalls SAM 350P, 360P, and 450P public defibrillators that may fail to deliver voice prompts during emergencies, potentially delaying critical therapy.
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
HeartSine is recalling its SAM 350P, SAM 360P, and SAM 450P public access defibrillators because they might not provide voice instructions during use. This could delay life-saving therapy if someone needs defibrillation during a cardiac emergency.
The defibrillator has a manufacturing issue that prevents it from delivering instructional voice prompts during use. While visual icons remain, this could lead to no therapy or delayed therapy in critical cardiac emergencies.
Public access defibrillators used in public places like parks, schools, or community centers are affected. People who use these devices during cardiac emergencies may be at risk if the device fails to provide voice prompts.
Check for the model numbers SAM 350P, SAM 360P, or SAM 450P on the device. Devices with serial numbers starting with prefixes like 16D, 16E, 16G, 17D, 17E, 17G, etc., are affected.
Look for the model number SAM 350P, SAM 360P, or SAM 450P on the defibrillator.
Reach out to HeartSine directly for guidance on next steps if you own an affected device.
The recall does not require immediate replacement; users should check if their device is affected and contact HeartSine for guidance.
The device may not deliver therapy or delay critical treatment during a cardiac emergency, which could be life-threatening.
Check for model numbers SAM 350P, SAM 360P, or SAM 450P, or serial numbers starting with prefixes like 16D, 16E, 16G, etc.
We’ve drafted a message you can send HeartSine to request your refund or repair — edit it as you like.
Subject: Recall Z-1820-2024 — HeartSine HeartSine Hello, I own a HeartSine that is covered by recall Z-1820-2024 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.
