FDAApril 8, 2024device

HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P

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

The hazard

Automated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user during use of the device. Visual instructional icons will still be present, but this issue could potentially lead to no therapy or a delay in therapy.

What to do

FDA enforcement status: Ongoing

Brands named

heartsine technologiesheartsine

UPCs

506016712537950601671206885060167125720506016712806650601671223305060167122491506016712251450601671213715060167120671506016712163050601671280425060167120701

Recall history

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

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