Recall Z-1280-2023
Withings · initiated December 19, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)
Codes / lots: UDI-DI 03700546706400 Serial numbers 00:24:e4:e6:94:a0 00:24:e4:ee:d6:a3 00:24:e4:ef:3d:52 00:24:e4:ef:2b:ca 00:24:e4:e6:d2:fe 00:24:e4:ef:22:d4 00:24:e4:c0:9e:e8 00:24:e4:c0:90:ff 00:24:e4:ee:b6:9a 00:24:e4:d3:ee:74 a4:7e:fa:02:33:88 a4:7e:fa:02:36:4d 00:24:e4:ef:46:09 00:24:e4:c0:8e:6c 00:24:e4:ef:0c:07 a4:7e:fa:02:34:3d 00:24:e4:e7:5f:ce 00:24:e4:c0:8a:df 00:24:e4:e6:da:83 00:24:e4:d3:ff:c2 00:24:e4:c0:86:f2 00:24:e4:ef:45:29 a4:7e:fa:02:58:e1 00:24:e4:c0:a3:f4 00:24:e4:e6:fb:5c 00:24:e4:c0:88:cc 00:24:e4:ee:d8:3b a4:7e:fa:02:37:55 00:24:e4:e7:4a:76 00:24:e4:e6:d6:f3 00:24:e4:c0:4b:08 00:24:e4:c0:ba:1a 00:24:e4:d3:fb:2c a4:7e:fa:02:39:6d 00:24:e4:d4:11:37 00:24:e4:e6:d0:1a a4:7e:fa:02:4a:71 00:24:e4:e7:41:dd a4:7e:fa:02:49:5e 00:24:e4:e6:c4:ca 00:24:e4:d3:fe:44 00:24:e4:ef:0a:db 00:24:e4:c0:90:31 00:24:e4:e6:8c:c4 00:24:e4:e7:32:eb 00:24:e4:a3:d4:2a 00:24:e4:e6:c9:ae 00:24:e4:d3:f9:ef 00:24:e4:c0:8a:7b 00:24:e4:d4:13:51 00:24:e4:e6:7d:f9 00:24:e4:e6:f5:65 a4:7e:fa:02:37:a5 00:24:e4:e6:f1:9c 00:24:e4:e6:ca:b7 00:24:e4:e7:58:76 00:24:e4:e6:f4:eb a4:7e:fa:02:93:af 00:24:e4:c0:aa:f1 00:24:e4:ee:b2:ac 00:24:e4:c0:a8:41 00:24:e4:e7:5f:30 00:24:e4:c0:52:6c 00:24:e4:e6:f5:9a…
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.
FDA-determined cause: Software Design Change
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).
Details
- Recall number
- Z-1280-2023
- Initiated
- December 19, 2022
- Posted by FDA
- March 22, 2023
- Product code
- DPS – Electrocardiograph
- Quantity
- 38,886 (US)
- Distribution
- Nationwide distribution in the US. No foreign distribution.
- Recalling firm
- Withings, Issy les Moulineaux CEDEX