Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Recall
- Recall Number
- Z-1280-2023
- Event Number
- 91523
- Firm
- Withings 37 Bis Rue Du General Leclerc Issy les Moulineaux CEDEX France
- FEI Number
- 3008820594
- Product Code
- DPS
- Status
- Open, Classified
- Root Cause
- Software Design Change
- Initiated
- December 19, 2022
- Posted
- March 22, 2023
Description
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
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.
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).
Nationwide distribution in the US. No foreign distribution.
38,886 (US)