Class II — Withings
| Recalling firm | Withings (France) |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2) |
| Quantity | 38,886 (US) |
| Distribution | Nationwide distribution in the US. No foreign distribution. |
| Initiated | 2022-12-19 |
| Classified | 2023-03-22 |
| Recall number | Z-1280-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Withings (Z-1280-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91523/
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