FDA-Device2024-05-22Class II
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
HeartSine Technologies Ltd
Hazard
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.
Sold states
US Nationwide distribution including in the states of AK, AL, AR, AS, AZ, CA, CO, CT, DC, DE, FL, GA, GC, HI, IA, ID, IL, IN, KS, KY, LA, MA, MB, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.
Affected count
183,248
Manufactured in
207 Airport Road West, N/A, Belfast, N/A, United Kingdom
Products
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1820-2024Don't want to check this manually?
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