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Withings recalls Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG
Recalled March 29, 2023 · FDA recall Z-1280-2023 · Withings
Hazard
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. · FDA Class II
Units
38,886 (US)
Sold at
Nationwide distribution in the US. No foreign distribution.
Description
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.
Product
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Manufacturer(s)
Withings
Made in
France
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →