Scan Monitor/ScanWatch — Class II medical device recall Z-1280-2023
Ongoing recall by Withings, reported 2023-03-29, distributed nationwide. A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the dev
| Recall number | Z-1280-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Withings, Issy les Moulineaux CEDEX, N/A, France |
| Recall initiated | 2022-12-19 |
| Classified | 2023-03-22 |
| Reported by FDA | 2023-03-29 |
| Distributed | Nationwide (US) |
| Quantity | 38,886 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03700546706400 |
| Model numbers | HWA09 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1280-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.