Recall Z-3270-2026— HeartSine Technologies Ltd
Class III · Ongoing
Class III FDA medical device recall by HeartSine Technologies Ltd, initiated 2026-07-27. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069. Reason: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check..
- Recalling firm
- HeartSine Technologies Ltd
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2026-07-27
- Firm location
- Belfast, United Kingdom
Product description
HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device, US English with Gateway - 2 Min CPR UDI-DI code: 0506016712804 HeartSine SAM 360P 360P US Device, US English - 2 Min CPR UDI-DI code: 0506016712068 HeartSine SAM 450P SAM 450P US Device, US English (2 min CPR) UDI-DI code: 0506016712069
Reason for recall
Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.
Data sourced from openFDA. This site is unofficial and independent of the FDA.