FDAFebruary 14, 2024device

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-UK-10; SAM 450P/450-UNIT-US-08, ; SAM 500P/500-BAS-UK-10

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

heartsine technologiesheartsine

UPCs

0506016712067105060167127670050601671276870506016712731150601671229270506016712977305060167122453

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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