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

Hazard

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

Details from the source

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 Quantity: 13 Lot/code info: REF/UDI-DI/Serial Numbers: SAM 350P/05060167120671/17D00006810, 19D00027547, 19D00030364, 20D00000454, 20D00000868, 20D00006232, 22D91125401, 16D01000729, 22D91145062; SAM 360P/5060167127120, 5060167128028/20E90006314, 21E91040881; SAM 500P/5060167126505, 5060167125843/17B00003113, 20B90000080

UPC codes

05060167120671, 5060167127120, 5060167128028, 5060167126505, 5060167125843

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.