Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) a
FDA device recall Z-1280-2023 · posted 2023-03-22 · Open, Classified
Recall details
- Recalling firm
- Withings
- 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.
- Action taken
- Users were initially notified via push notifications in the companion app on December 19, 2022, which instructed users to update the app and activate the ECG feature under a physician. On February 10, 2023, the firm followed up with customers via Medical Device Recall letters. Customers were instructed to ensure their Health Mate app is updated to iOS 5.13.0 or higher, and to ensure their device is synchronized with the Health Mate app. Customers should follow the instructions on their Health Mate app to activate their ECG feature. Contact Information for questions: Email: deals-support@withings.com Phone number: 1-888-229-4116 (Availability Mon - Fri, 08:00 - 22:00 EST, 13:00 - 03:00 GMT, 14:00 - 04:00 CET).
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- DPS
- Quantity affected
- 38,886 (US)
- Distribution
- Nationwide distribution in the US. No foreign distribution.
- Date initiated
- 2022-12-19
- Date posted
- 2023-03-22
- Location
- Issy les Moulineaux CEDEX, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Scan Monitor (K201456) | Withings SA | 2021-10-05 |