FDA recall Z-2143-2023

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2023-04-26

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belfast, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2143-2023