Recall Z-2143-2023— HeartSine Technologies Ltd
Class II · Ongoing
Class II FDA medical device recall by HeartSine Technologies Ltd, initiated 2023-04-26. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P. Reason: Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly..
- Recalling firm
- HeartSine Technologies Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-04-26
- Firm location
- Belfast, N/A, United Kingdom
Product description
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
Reason for recall
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.
Data sourced from openFDA. This site is unofficial and independent of the FDA.