Use caution Medical device recall · FDA · Published February 1, 2023

HeartSine Samaritan PAD Defibrillators: Incorrect Language May Delay Life-Saving Therapy

HeartSine recalls SAM 350P, 360P, and 500P defibrillators that may have incorrect language settings, risking delayed or no life-saving shocks during cardiac emergencies.

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

🇺🇸 FDA recall #Z-1217-2023Medical device HeartSine ›

Use caution until it’s fixed

Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/58976-heartsine-samaritan-pad-defibrillators-incorrect-language-may-delay-life-saving.

Source Summary by GovInfoNow · govinfonow.com/recall/58976-heartsine-samaritan-pad-defibrillators-incorrect-language-may-delay-life-saving · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1217-2023

Cite this page

“HeartSine Samaritan PAD Defibrillators: Incorrect Language May Delay Life-Saving Therapy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58976-heartsine-samaritan-pad-defibrillators-incorrect-language-may-delay-life-saving. Based on FDA recall #Z-1217-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1217-2023%22&limit=1).

The Food and Drug Administration announced on Feb. 1, 2023, that HeartSine Technologies Ltd is recalling Heartsine Samaritan PAD defibrillators due to potential incorrect language configurations that can delay or prevent therapy. The agency issued recall number Z-1217-2023 for the voluntary Class II action.

How to tell if you have it

Brand: HeartSine
Product: SAM 350P semi-automatic defibrillator, REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062
Product: SAM 360P fully automatic defibrillator, REF/UDI-DI/Serial Numbers: SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881
Product: SAM 500P semi-automatic defibrillator with CPR Advisor, REF/UDI-DI/Serial Numbers: SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080
Distribution: US (NJ, PA, WI, NE, TX, CA, AZ, AR) and OUS (Australia, Czechia, Canada, New Zealand)
Units affected: 13

The hazard

According to the FDA, the automated external defibrillators were potentially distributed with the incorrect language configuration. This defect can lead to a delay in therapy or no therapy being delivered.

Context

GovInfoNow's records show HeartSine Technologies Ltd has 7 other recalls on record since April 26, 2023. Recent brand actions include the July 27, 2026 recall of HeartSine iECG products for missing maintenance supplements and the same date recall of HeartSine 350P US Device due to a damaged membrane tail. Other recent recalls of similar products include Philips Cardiac Workstation 7000 (July 1, 2026), Philips Cardiac Workstation 5000 (July 1, 2026), and Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray (Nov. 6, 2025).

How to tell if you have this one

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.

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 on your defibrillator (SAM 350P, SAM 360P, or SAM 500P) and compare it to the list of serial numbers provided in the recall.

Where it went and when

Where it was distributed

Distributed in 8 states, and outside the U.S.

FDA distribution: “US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Arkansas, California, Nebraska, New Jersey, Pennsylvania, Texas, Wisconsin.

Recall timeline

FDA published this recall 42 days after the firm started it.

Feb 1, 2023Firm started the recall
Mar 3, 2023FDA classified it Class II
Mar 15, 2023Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using my defibrillator immediately?

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.

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Link to this recall

<a href="https://govinfonow.com/recall/58976-heartsine-samaritan-pad-defibrillators-incorrect-language-may-delay-life-saving">HeartSine Samaritan PAD Defibrillators: Incorrect Language May Delay Life-Saving Therapy (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-1217-2023 (February 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1217-2023 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.