Withings: Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturation (SpO2)

Hazard

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.

Details from the source

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. Distribution: Nationwide distribution in the US. No foreign distribution. Quantity: 38,886 (US) Lot/code info: 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 00:24:e4:ee:b7:c8 00:24:e4:e6:c8:69 00:24:e4:ef:37:2c 00:24:e4:d3:fc:73 00:24:e4:d3:f4:b3 00:24:e4:e6:d9:bc a4:7e:fa:02:2f:bc 00:24:e4:e7:2d:0b 00:24:e4:e7:60:7b 00:24:e4:c0:b4:aa 00:24:e4:c0:a5:31 00:24:e4:d4:04:85 00:24:e4:ef:2b:ab 00:24:e4:d3:fc:65 a4:7e:fa:02:4a:3e 00:24:e4:e7:5c:4d a4:7e:fa:02:9c:47 00:24

UPC codes

03700546706400

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.