Recall Z-1280-2023 — Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
U.S. FDA — Device Enforcement · France · 2022-12-19 · Class II
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Reported risk: A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.
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