Recall Z-1820-2024— HeartSine Technologies Ltd
Class II · Ongoing
Class II FDA medical device recall by HeartSine Technologies Ltd, initiated 2024-04-08. FDA's recall record names no specific 510(k) clearance for this event. Product: HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P. Reason: Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy..
- Recalling firm
- HeartSine Technologies Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-04-08
- Firm location
- Belfast, N/A, United Kingdom
Product description
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Reason for recall
Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.
Data sourced from openFDA. This site is unofficial and independent of the FDA.