Recall Z-1280-2023 ยท DPS Electrocardiograph
Withings
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
| Date | Mar 22, 2023 (initiated Dec 19, 2022) |
| Status | Open, Classified |
| 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. |
| Root cause | Software Design Change |
| Action | 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@with |
| Quantity | 38,886 (US) |
| Distribution | Nationwide distribution in the US. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201456 | Scan Monitor Withings SA, Oct 5, 2021 |