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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1217-2023 |
| Event ID | 91659 |
| Event Description | Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor |
| Product Type | Devices |
| Distribution | US: NJ, PA, WI, NE, TX, PA, CA, AZ, AR OUS: Australia, Czechia, Canada, New Zealand |
| Quantity | 13 |
| Recall Reason | Automated external defibrillators were potentially distributed with the incorrect language configuration, which can lead to a delay in therapy or no therapy. |
| Device Classification | 20230315 |
| Device Code Info | 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 |
| Center Classification Date | 20230303 |
| Recall Initiation Date | 20230201 |
| Recalling Firm | HeartSine Technologies Ltd |
| Initial Notification | Letter |
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