FDA recall Z-1217-2023

Product

Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor

Reason for recall

Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.

Distribution

US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand

Key facts

Status

Ongoing

Initiation date

2023-02-01

Report date

2023-03-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Belfast, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1217-2023