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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Monitoring Devices

HeartSine Technologies Ltd: HeartSine samaritan PAD Defibrillators Recalled for Configuration Error

Agency Publication Date: February 15, 2024
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Summary

HeartSine Technologies is recalling 12 samaritan Public Access Defibrillators (PAD) because they were shipped in a test configuration rather than a clinical one. This defect causes the devices to provide incorrect instructions, such as prompting users to perform CPR for only 5 seconds and attempting to deliver shocks every 5 seconds if a shockable rhythm is found. These devices were distributed worldwide, including in Texas, California, Illinois, Colorado, Florida, North Carolina, and Michigan. Consumers should contact the manufacturer immediately to resolve this issue as the device may not provide life-saving therapy during a cardiac emergency.

Risk

The device may provide incorrect voice and visual prompts, leading to significantly shortened CPR cycles and rapid shock analysis. This can result in the patient receiving no therapy or delayed therapy during a life-threatening cardiac event.

What You Should Do

  1. Locate your HeartSine samaritan PAD and check the model and serial number on the device label. Affected models include SAM 350P, SAM 360P, SAM 450P, and SAM 500P.
  2. Check your device against the following serial numbers: 17D00023014, 18D00020508, 19D00017655, 20D00006524, 21D91081653, 22D91152391 (SAM 350P); 21E91049810, 23E90001379, 23E90010409 (SAM 360P); 17G00001893, 18G00001553 (SAM 450P); and 22B91071233 (SAM 500P).
  3. Verify the UDI-DI or GTIN on your packaging: 05060167120671, 05060167127670, 05060167127687, 05060167127311, 5060167122927, 05060167129773, or 05060167122453.
  4. Immediately contact HeartSine Technologies or your medical device provider for instructions on how to correct the configuration settings or return the device.
  5. Contact your healthcare provider if you have any medical concerns regarding the use of this device.
  6. For further information, you may contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Corrective configuration update or manufacturer instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: HeartSine samaritan PAD (Public Access Defibrillator) SAM 350P
Model / REF:
SAM 350P
350-UNIT-US-10
350-STR-US-10
350-STR-UK-10
UPC Codes:
05060167120671
05060167127670
Lot Numbers:
17D00023014
18D00020508
19D00017655
20D00006524
21D91081653
22D91152391
Product: HeartSine samaritan PAD (Public Access Defibrillator) SAM 360P
Model / REF:
SAM 360P
360-STR-JA-10
360-STR-DE-10
360-STR-UK-10
UPC Codes:
05060167127687
05060167127311
5060167122927
Lot Numbers:
21E91049810
23E90001379
23E90010409
Product: HeartSine samaritan PAD (Public Access Defibrillator) SAM 450P
Model / REF:
SAM 450P
450-UNIT-US-08
UPC Codes:
05060167129773
Lot Numbers:
17G00001893
18G00001553
Product: HeartSine samaritan PAD (Public Access Defibrillator) SAM 500P
Model / REF:
SAM 500P
500-BAS-UK-10
UPC Codes:
05060167122453
Lot Numbers:
22B91071233

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93962
Status: Active
Manufacturer: HeartSine Technologies Ltd
Sold By: Authorized Medical Device Distributors
Manufactured In: United Kingdom
Units Affected: 12
Distributed To: Texas, California, Illinois, Colorado, Florida, North Carolina, Michigan

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.