Use cautionMedical device recall · FDA · Published February 14, 2024
HeartSine Samaritan PAD Defibrillator Recalled: Incorrect CPR Instructions Risk
HeartSine recalls specific Samaritan PAD defibrillators with potential for incorrect CPR prompts and shock intervals, risking delayed life-saving therapy. Affected units have unique model numbers and were sold in the US, UK, and Japan.
Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.
Take action
Contact the company
📍Recalling firmHeartSine Technologies Ltd207 Airport Road West · Belfast, United Kingdom
“HeartSine Samaritan PAD Defibrillator Recalled: Incorrect CPR Instructions Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56164-heartsine-samaritan-pad-defibrillator-recalled-incorrect-cpr-instructions-risk. Based on FDA recall #Z-1141-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1141-2024%22&limit=1).
The FDA announced on Feb. 14, 2024, that HeartSine Technologies Ltd is recalling specific HeartSine samaritan PAD public access defibrillators due to a test configuration hazard. This error may cause the device to prompt incorrect CPR duration and shock intervals, potentially leading to no therapy or delayed therapy.
How to tell if you have it
Brand: HeartSine
Product: samaritan PAD (Public Access Defibrillator)
Catalog Numbers: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-UK-10; SAM 450P/450-UNIT-US-08; SAM 500P/500-BAS-UK-10
Units Affected: 12
The hazard
According to the FDA, the automated external defibrillators were shipped in their test configuration. This results in incorrect language and CPR duration, prompting users to perform CPR for only 5 seconds and analyze heart rhythm every 5 seconds if a shockable rhythm is detected. This could potentially lead to no therapy or delayed therapy.
Context
GovInfoNow's records show HeartSine Technologies Ltd has issued 7 other recalls since Feb. 1, 2023. On July 27, 2026, the company recalled products distributed without a required Maintenance Supplement and devices with damaged membrane tails causing intermittent faults. Other recent recalls of similar products include Philips Cardiac Workstation 7000 (July 1, 2026), Philips Cardiac Workstation 5000 (July 1, 2026), and Thoratec HeartMate 3 LVAS Kits (May 13, 2026).
How to tell if you have this one
Check for model numbers like SAM 350P/350-UNIT-US-10 or SAM 360P/360-STR-JA-10. The device was sold in the US, UK, and Japan between 2008 and 2017 based on the serial numbers.
Brand
HeartSine
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Look for model numbers such as SAM 350P/350-UNIT-US-10 or SAM 360P/360-STR-JA-10 on the device label.
Contact HeartSine
Reach out to HeartSine Technologies Ltd for verification of your device's model and instructions on next steps.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Illinois, Michigan, North Carolina, Texas.
Recall timeline
FDA published this recall 7 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1141-2024 (February 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1141-2024 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.