Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Reported: March 29, 2023 Initiated: December 19, 2022 #Z-1280-2023
Product Description
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Reason for Recall
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.
Details
- Recalling Firm
- Withings
- Units Affected
- 38,886 (US)
- Distribution
- Nationwide distribution in the US. No foreign distribution.
- Location
- Issy les Moulineaux CEDEX, N/A
Frequently Asked Questions
What product was recalled? ▼
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2). Recalled by Withings. Units affected: 38,886 (US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 29, 2023. Severity: Moderate. Recall number: Z-1280-2023.
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