FDA-Device2023-07-19Class II
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
HeartSine Technologies Ltd
Hazard
Single use battery and electrode cartridge may be rendered inoperable due to depleted battery cells which could prevent the defibrillator from analyzing patient condition or delivering therapy correctly.
Sold states
Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI and OUS (countries of): Australia, Canada, Denmark, France, Iceland, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Peru, Poland, Singapore, South Africa, Spain, Thailand, & United Kingdom.
Affected count
30,022 units
Manufactured in
207 Airport Road West, N/A, Belfast, N/A, United Kingdom
Products
HeartSine, REF: PAD-PAK-01, PAD-PAK-03 AND PAD-PAK-03j, CE0123 sold separately and with the HeartSine Samaritan Public Access Defibrillator models: 350P/360P/450P/500P
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2023Don't want to check this manually?
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