HEARTSINE TECHNOLOGIES, LTD FDA Inspection Record
HEARTSINE TECHNOLOGIES, LTD is an FDA-registered facility (FEI 3004123209) located in BELFAST Northern Ireland, GB. RegDataLab tracks 3 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Apr 12, 2018: No Action Indicated (NAI)
- Inspections on record
- 3 (1 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 10, latest Jul 27, 2026
- Import refusals
- 4
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 12, 2018 | No Action Indicated (NAI) | No citations listed |
| Feb 12, 2015 | No Action Indicated (NAI) | No citations listed |
| Jan 28, 2011 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design validation- Lack of or inadequate procedures (21 CFR 820.30(g)) Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 27, 2026 | Class II | Z-3120-2026 | HeartSine SAM 350P
350P US Device, US English - 2 Min CPR
UDI-DI… Due to a damaged (over stretched) membrane tail that causes an intermittent fault. |
| Jul 27, 2026 | Class III | Z-3270-2026 | HeartSine samaritan PAD (Public Access Defibrillator);
HeartSine SAM 350P
350P US… Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the… |
| Sep 18, 2025 | Class II | Z-0288-2026 | HeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07… Due to customer complaints, defibrillator pads may contain damage pins that disrupt the mechanical fit and electrical contact. |
| Jun 30, 2025 | Class II | Z-2174-2025 | HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P
The HeartSine… Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) |
| Apr 8, 2024 | Class II | Z-1820-2024 | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to… |
| Feb 14, 2024 | Class II | Z-1141-2024 | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM… Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR… |
| Apr 26, 2023 | Class II | Z-2143-2023 | HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with… Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator… |
| Feb 1, 2023 | Class II | Z-1217-2023 | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator,
SAM 360P fully automatic… Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in… |
| Jun 12, 2014 | Class II | Z-2115-2014 | Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM… A small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. |
| Sep 13, 2012 | Class I | Z-0124-2013 | HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917… Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver… |
FDA record score
22 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
10 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-3120-2026, this FEI as the recalling firm | Jul 27, 2026 | 4 x 1 | 4 |
| Class II recall Z-0288-2026, this FEI as the recalling firm | Sep 18, 2025 | 4 x 1 | 4 |
| Class II recall Z-2174-2025, this FEI as the recalling firm | Jun 30, 2025 | 4 x 1 | 4 |
| Class II recall Z-1820-2024, this FEI as the recalling firm | Apr 8, 2024 | 4 x 0.6 | 2.4 |
| Class II recall Z-1141-2024, this FEI as the recalling firm | Feb 14, 2024 | 4 x 0.6 | 2.4 |
| Class II recall Z-2143-2023, this FEI as the recalling firm | Apr 26, 2023 | 4 x 0.6 | 2.4 |
| Class II recall Z-1217-2023, this FEI as the recalling firm | Feb 1, 2023 | 4 x 0.6 | 2.4 |
| Class II recall Z-2115-2014, this FEI as the recalling firm | Jun 12, 2014 | 10 years or older, so it adds no points | 0 |
| Class I recall Z-0124-2013, this FEI as the recalling firm | Sep 13, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Jan 28, 2011 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- HeartSine Technologies Ltd
- Location
- BELFAST Northern Ireland (GB)
- Source
- device