Recall Z-1217-2023— HeartSine Technologies Ltd
Class II · Ongoing
Class II FDA medical device recall by HeartSine Technologies Ltd, initiated 2023-02-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor. Reason: Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy..
- Recalling firm
- HeartSine Technologies Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-01
- Firm location
- Belfast, United Kingdom
Product description
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Reason for recall
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.