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HeartSine Technologies Ltd recalls Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-
Recalled March 15, 2023 · FDA recall Z-1217-2023 · HeartSine Technologies
Hazard
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. · FDA Class II
Units
13
Sold at
US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
Description
Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Product
Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Manufacturer(s)
HeartSine Technologies Ltd
Made in
United Kingdom
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →