CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report
HeartSine samaritan PAD (Public Access Defibrillator): Type recalled
HeartSine Technologies is recalling HeartSine samaritan PAD (Public Access Defibrillator): Type, distributed nationwide in the US. The recall was initiated on 14 Feb 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1141-2024
- FDA event ID
- 93962
- Recalling firm
- HeartSine Technologies, Belfast, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Feb 2024
- FDA classified
- 15 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 14 Feb 2024 | Recall initiated by company | |
| 15 Feb 2024 | Classified by FDA | +1 day |
| 21 Feb 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: 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
Where it was distributed
Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.
Nationwide CaliforniaColoradoFloridaIllinoisMichiganNorth CarolinaTexas
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Type/UDI-DI or GTIN/Serial Number: SAM 350P/05060167120671, 05060167127670, +M727SAM350P0/$$+7/17D00023014, 18D00020508, 19D00017655, 20D00006524, 21D91081653, 22D91152391; SAM 360P/05060167127687, 05060167127311,5060167122927/21E91049810, 23E90001379, 23E90010409; SAM 450P/05060167129773, +M727SAM450P0/$$+7, +M727SAM450P0/$$+7/17G00001893, 18G00001553; SAM 500P/05060167122453/22B91071233
Where was it sold?
Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from HeartSine Technologies
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HeartSine Pad-Pak recalled by HeartSine Technologies | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine samaritan PAD (Public Access Defibrillator), Type recalled | HeartSine Technologies | Other | Nationwide |
| Device | CLASS II | HeartSine, REF: Pad-pak-01, Pad-pak-03 AND Pad-pak-03j, CE0123 sold recalled | HeartSine Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | Heartsine Samaritan PAD: SAM 350P semi-automatic recalled | HeartSine Technologies | Other | 8 states |
| Device | CLASS II | Pad-Pak and Pedi-Pak accessories recalled by Heartsine Technologies | Heartsine Technologies | Packaging Defects | Nationwide |
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