Withings recalls Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG)…

Recall date

December 19, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1280-2023

FDA classification

Class II

Brand / firm

Withings

Sold / distributed

Nationwide distribution in the US. No foreign distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)