Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Reported: March 15, 2023 Initiated: February 1, 2023 #Z-1217-2023
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.
Details
- Recalling Firm
- HeartSine Technologies Ltd
- Units Affected
- 13
- Distribution
- US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
- Location
- Belfast
Frequently Asked Questions
What product was recalled? ▼
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor. Recalled by HeartSine Technologies Ltd. Units affected: 13.
Why was this product recalled? ▼
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1217-2023.
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