Recall Z-1280-2023— Withings
Class II · Ongoing
Class II FDA medical device recall by Withings, initiated 2022-12-19. It names one FDA 510(k) clearance: K201456. Product: Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2). 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..
- Recalling firm
- Withings
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-19
- Firm location
- Issy les Moulineaux CEDEX, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.