Wearable ECG smartwatch software bug eliminates physician review
Withings Scan Monitor/ScanWatch (model hwa09) has a software defect preventing physicians from reviewing ECG recordings, which is critical to the device's FDA clearance requirement for physician-supervised use. Users should discontinue use until the defect is corrected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a software defect that removes a critical safety feature (physician ECG review) required by the device's clearance. The hazard represents a risk-of-harm scenario where the device could be used outside its approved parameters, but no illnesses or injuries have been reported.
Plain-English summary
Withings is recalling the Scan Monitor/ScanWatch (model hwa09), a wearable Bluetooth-connected device that records heart activity (ECG) and blood oxygen saturation (SpO2). Approximately 38,886 units were distributed nationwide in the United States.
A software defect has eliminated the initial ECG activation and the physician review function. The device is FDA-cleared specifically for use under physician supervision, and the ability to review ECG recordings is essential to its approved use. The software bug compromises this critical safety feature by preventing physicians from reviewing ECG data.
Users of affected devices should discontinue use immediately. Withings should be contacted for instructions on obtaining a software update that restores full ECG functionality and physician review capability.
The recalled product
- Product
- Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
- Manufacturer
- Withings
- Affected units
- 38,886
Distribution
Distributed nationwide across the United States.
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