Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
FDA Recall Z-1280-2023 · Posted 2023-03-22
Recalling FirmWithings
Recall StatusOpen, Classified
Product CodeDPS
Date Initiated2022-12-19
Product Quantity38,886 (US)
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.
Firm 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: [email protected]
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
Distribution Pattern
Nationwide distribution in the US. No foreign distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.