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Recall Observatory FDA recall evidence

Device product

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

Z-1217-2023

February 01, 2023

Class II

Product summary

Firm
HeartSine Technologies Ltd
Event
Event 91659
Status
Ongoing
Classification
Class II
Quantity
13
Official record key
device-enforcement:Z-1217-2023

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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