Use caution Medical device recall · FDA · Published April 8, 2024

HeartSine Samaritan PAD Defibrillators May Not Give Voice Prompts During Use

HeartSine recalls SAM 350P, 360P, and 450P public defibrillators that may fail to deliver voice prompts during emergencies, potentially delaying critical therapy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1820-2024Medical device HeartSine ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmHeartSine Technologies Ltd207 Airport Road West · Belfast, United Kingdom

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/55442-heartsine-samaritan-pad-defibrillators-may-not-give-voice-prompts-during.

Source Summary by GovInfoNow · govinfonow.com/recall/55442-heartsine-samaritan-pad-defibrillators-may-not-give-voice-prompts-during · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1820-2024

Cite this page

“HeartSine Samaritan PAD Defibrillators May Not Give Voice Prompts During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55442-heartsine-samaritan-pad-defibrillators-may-not-give-voice-prompts-during. Based on FDA recall #Z-1820-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1820-2024%22&limit=1).

The FDA announced on April 8, 2024, that HeartSine Technologies Ltd is recalling HeartSine samaritan PAD public access defibrillators due to a manufacturing issue that could prevent instructional voice prompts from playing. The agency said the defect might lead to no therapy or a delay in therapy. Owners should contact the company for details.

How to tell if you have it

Brand: HeartSine
Product: samaritan PAD (Public Access Defibrillator)
Models: SAM 350P, SAM 360P, SAM 450P
UDI-DI codes: 5060167125379, 5060167120688, 5060167125720, 5060167128066, 5060167122330, 5060167122491, M727SAM450P, 5060167122514, 5060167121371, 5060167120671, 5060167121630, 5060167128042, 5060167120701, 5060167128080, 5060167120695, 5060167120725, 5060167120718, 5060167120909, 5060167120916, 5060167122071, 5060167120893
Device prefixes: 16D, 16E, 16G, 17D, 17E, 17G, 18D, 18E, 18G, 19D, 19E, 19G, 20D, 20E, 20G, 21D, 21E, 21G, 22D, 22E, 22G, 23D, 23E, 23G, 24D, 24E, 24G
Quantity: 183,248 units

The hazard

The FDA said the automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use. While visual instructional icons will still be present, this issue could potentially lead to no therapy or a delay in therapy.

Context

GovInfoNow's records show HeartSine Technologies Ltd has had 7 other recalls on record since February 1, 2023. Other recent recalls of similar products include the HeartSine iECG recall on July 27, 2026, and the HeartSine 350P US Device recall on July 27, 2026. A September 18, 2025 recall involved HeartSine Pad-Pak Defibrillator Pads that may have damaged pins.

How to tell if you have this one

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.

Brand
HeartSine
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number SAM 350P, SAM 360P, or SAM 450P on the defibrillator.
Contact HeartSine
Reach out to HeartSine directly for guidance on next steps if you own an affected device.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 44 days after the firm started it.

Apr 8, 2024Firm started the recall
May 14, 2024FDA classified it Class II
May 22, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/55442-heartsine-samaritan-pad-defibrillators-may-not-give-voice-prompts-during">HeartSine Samaritan PAD Defibrillators May Not Give Voice Prompts During Use (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1820-2024 (April 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1820-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.