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HeartSine Technologies Ltd Recall 91659

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

HeartSine Technologies Ltd Recall 91659 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1217-2023
Event ID91659
Event DescriptionHeartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
Product TypeDevices
DistributionUS: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand
Quantity13
Recall ReasonAutomated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy.
Device Classification20230315
Device Code InfoREF/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
Center Classification Date20230303
Recall Initiation Date20230201
Recalling FirmHeartSine Technologies Ltd
Initial Notification Letter
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