Brand
Withings
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Withings and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-03-29FDA-DeviceClass IIScan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
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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