FDA-Device2023-03-29Class II
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
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.
Sold states
Nationwide distribution in the US. No foreign distribution.
Affected count
38,886 (US)
Manufactured in
37 Bis Rue Du General Leclerc, N/A, Issy les Moulineaux CEDEX, N/A, France
Products
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1280-2023Don't want to check this manually?
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