Reported Mar 15, 2023 · Ongoing

Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P…

HeartSine Technologies Ltd.

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: HeartSine Technologies Ltd · 207 Airport Road West · Belfast · N/A

Is this the product you have?

  • Heartsine Samaritan PADSAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Lot codes and dates

3 of 3 products

Products covered by this recall
#BarcodesProduct as published
105060167120671SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062
250601671271205060167128028SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881
350601671265055060167125843SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080
Amount recalled
13

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.