# FDA recall Z-1280-2023

> **Withings** · Class II · device recall initiated 2022-12-19.

## 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.

## Distribution

Nationwide distribution in the US. No foreign distribution.

## Key facts

- **Recall number:** Z-1280-2023
- **Recalling firm:** Withings
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-19
- **Report date:** 2023-03-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Issy les Moulineaux CEDEX, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1280-2023

## Citation

> AI Analytics. FDA recall Z-1280-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1280-2023. Source: US FDA. Licensed CC0.

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