FDADecember 19, 2022device
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Official recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Ongoing
Brands named
withings
UPCs
03700546706400
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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