HeartSine Technologies Ltd: HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P/350-UNIT-US-10, 350-STR-US-10, 350-STR-UK-10; SAM 360P/360-STR-JA-10, 360-STR-DE-10, 360-STR-U

Hazard

Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy.

Details from the source

Reason for recall: Automated external defibrillators were shipped in their test configuration so there is a potential to have incorrect language, and CPR duration resulting in the device prompting users to perform CPR for 5-seconds, and it could analyze heart rhythm and instruct users to deliver a shock every 5-seconds if a shockable heart rhythm is detected, potentially leading to no therapy or delayed therapy. Distribution: Worldwide - US Nationwide distribution in the states of TX, CA, IL, CO, FL, NC, MI and the countries of Netherlands, Japan, New Zealand. Quantity: 12 Lot/code info: Type/UDI-DI or GTIN/Serial Number: SAM 350P/05060167120671, 05060167127670, +M727SAM350P0/$$+7/17D00023014, 18D00020508, 19D00017655, 20D00006524, 21D91081653, 22D91152391; SAM 360P/05060167127687, 05060167127311,5060167122927/21E91049810, 23E90001379, 23E90010409; SAM 450P/05060167129773, +M727SAM450P0/$$+7, +M727SAM450P0/$$+7/17G00001893, 18G00001553; SAM 500P/05060167122453/22B91071233

UPC codes

05060167120671, 05060167127670, 05060167127687, 05060167127311, 5060167122927, 05060167129773, 05060167122453

Source

Official record: FDA (Device enforcement) ↗

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