FDA Device recall Z-1280-2023

Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturatio…

FDA Device
Class II
ongoing
Published 2023-03-29

On 2023-03-29 the FDA classified a Class II recall of Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG) and oxygen saturatio… by Withings, citing 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.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1280-2023
Classification	Class II
Status	ongoing
Initiated	2022-12-19
Published	2023-03-29
Last updated	2026-09-13 11:56 UTC
Company	Withings
Distribution	US

Product

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

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.

Identifiers

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:… 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

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:…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1280-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.