Recall Z-2174-2025— HeartSine Technologies Ltd
Class II · Ongoing
Class II FDA medical device recall by HeartSine Technologies Ltd, initiated 2025-06-30. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator). Reason: Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks).
- Recalling firm
- HeartSine Technologies Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-06-30
- Firm location
- Belfast, United Kingdom
Product description
HeartSine SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P The HeartSine samaritan¿ PAD (Public Access Defibrillator)
Reason for recall
Due to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks)
Data sourced from openFDA. This site is unofficial and independent of the FDA.