Heartsine Technologies Ltd.. HeartSine SAM 350P 350P US Device, US English

Source: FDA | Recall date: 07/27/2026

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Affected product: HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 350P US Device, US English (American Airlines) - 2 Min CPR UDI-DI code: 0506016712207 350P US Device

Brand: heartsine technologies ltd

Hazard: Products were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check.

Official identifiers

FDA recall number: Z-3270-2026
FDA event number: 98483

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