Issy les Moulineaux CEDEX, N/A, France
Withings recalls
1 recall recorded since 2018, most recently on 19 December 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 19 December 2022
- Reason
- 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.
- Distribution
- Nationwide distribution in the US. No foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1280-2023
- Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.