FDA-Device2023-03-15Class II
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
HeartSine Technologies Ltd
Hazard
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Sold states
US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
Affected count
13
Manufactured in
207 Airport Road West, Belfast, United Kingdom
Products
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1217-2023Don't want to check this manually?
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