Recall archive / FDA device enforcement
Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wrist watch that records heart activity (ECG... — FDA record Z-1280-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Withings
- Quantity
- 38,886 (US)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1280-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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:e4:d3:f9:80 00:24:e4:e7:2c:f3 00:24:e4:e7:57:3d 00:24:e4:c0:9f:b0 a4:7e:fa:02:39:4e a4:7e:fa:02:3f:40 00:24:e4:e6:f1:98 00:24:e4:ee:c2:14 00:24:e4:e7:50:48 00:24:e4:e7:3d:7d 00:24:e4:ef:3a:bc 00:24:e4:d4:18:6d 00:24:e4:e7:43:39 00:24:e4:e7:45:4c 00:24:e4:c0:2b:bb 00:24:e4:ef:55:6d 00:24:e4:d3:fc:92 00:24:e4:e6:c9:7f 00:24:e4:d4:1b:71 00:24:e4:d4:23:56 00:24:e4:ef:2f:5f 00:24:e4:d4:24:a7 00:24:e4:ef:2b:03 00:24:e4:c0:8f:52 00:24:e4:d3:ed:4b 00:24:e4:d3:f5:2c 00:24:e4:d4:15:a5 00:24:e4:c0:88:8d 00:24:e4:e6:92:bc 00:24:e4:c0:be:23 00:24:e4:e6:c6:b1 00:24:e4:d3:f3:c2 00:24:e4:c0:8f:a8 00:24:e4:e7:2f:a1 00:24:e4:d4:15:4a 00:24:e4:e7:3a:13 00:24:e4:d3:fe:4a 00:24:e4:c0:a0:ba 00:24:e4:c0:ba:eb 00:24:e4:e7:5f:b5 00:24:e4:e6:88:66 00:24:e4:c0:84:77 00:24:e4:c0:74:d9 00:24:e4:ee:cd:27 00:24:e4:ee:b8:22 00:24:e4:c0:a5:f0 00:24:e4:c0:95:79 00:24:e4:e6:a9:b9 00:24:e4:e6:89:eb 00:24:e4:d3:f6:b0 00:24:e4:d4:07:65 00:24:e4:d4:04:d1 00:24:e4:e7:61:31 00:24:e4:d4:16:92 00:24:e4:c0:9b:87 00:24:e4:c0:78:f6 00:24:e4:e7:4b:1c 00:24:e4:d3:fd:7a 00:24:e4:e6:cd:17 00:24:e4:c0:ae:8c 00:24:e4:d4:1d:bd 00:24:e4:e7:0d:db 00:24:e4:ef:4f:c1 00:24:e4:ef:05:cb 00:24:e4:c0:91:c0 a4:7e:fa:02:31:dc 00:24:e4:d4:09:2b 00:24:e4:e7:2f:fa 00:24:e4:c0:9f:e4 00:24:e4:c0:9f:3e 00:24:e4:d3:f0:5a 00:24:e4:e6:d5:d1 00:24:e4:e6:de:c5 a4:7e:fa:02:24:72 00:24:e4:d4:09:5f 00:24:e4:c0:97:57 00:24:e4:e7:3f:a6 00:24:e4:e7:40:91 00:24:e4:c0:be:16 00:24:e4:d4:18:4f 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00:24:e4:ee:ce:c7 00:24:e4:e6:c9:c0 00:24:e4:ee:af:59 00:24:e4:d3:f1:ee 00:24:e4:e7:59:4b 00:24:e4:e6:d8:49 00:24:e4:e7:32:f6 00:24:e4:d4:1c:19 00:24:e4:c0:83:50 00:24:e4:e7:3c:e1 00:24:e4:d4:02:dc 00:24:e4:ef:46:4d 00:24:e4:e7:57:83 a4:7e:fa:02:94:bd 00:24:e4:e6:d9:aa a4:7e:fa:02:49:d2 00:24:e4:ee:bd:e7 00:24:e4:c0:24:c8 a4:7e:fa:02:37:54 00:24:e4:e7:43:45 00:24:e4:c0:4c:bc 00:24:e4:d3:f1:ff 00:24:e4:ee:cc:03 00:24:e4:e6:da:0d 00:24:e4:e7:47:5f 00:24:e4:e6:ac:1d 00:24:e4:c0:91:4e 00:24:e4:e7:2b:cb 00:24:e4:ef:37:cd a4:7e:fa:02:3a:c4 00:24:e4:b1:2f:8e 00:24:e4:ee:c8:fc 00:24:e4:ef:28:29 00:24:e4:e7:3e:24 00:24:e4:e7:53:fc 00:24:e4:c0:b3:83 00:24:e4:e7:28:b4 00:24:e4:e6:7d:b7 00:24:e4:e6:cb:6f 00:24:e4:ee:db:6e 00:24:e4:d4:0d:a1 00:24:e4:c0:b0:78 00:24:e4:ee:c7:70 00:24:e4:d4:15:54 00:24:e4:ef:58:96 00:24:e4:c0:27:54 00:24:e4:ef:0d:a9 00:24:e4:d3:f4:00 00:24:e4:ee:c9:e2 00:24:e4:ef:2e:81 00:24:e4:d4:23:67 00:24:e4:d5:07:c4 00:24:e4:d4:0e:40 00:24:e4:ef:0b:91 00:24:e4:e7:4b:b6 00:24:e4:d4:17:4f 00:24:e4:e6:c6:cd 00:24:e4:e6:f8:4a 00:24:e4:ef:2d:5e 00:24:e4:e6:a1:7c a4:7e:fa:02:31:9b 00:24:e4:d4:16:6f 00:24:e4:e6:d0:95 00:24:e4:ef:2c:c6 00:24:e4:e6:96:b2 00:24:e4:d4:0b:87 00:24:e4:ee:c9:e9 00:24:e4:e7:3a:c0 00:24:e4:d3:fb:52 a4:7e:fa:02:a1:8a a4:7e:fa:02:30:1a 00:24:e4:c0:2f:6d 00:24:e4:ef:53:7c 00:24:e4:e6:86:5a 00:24:e4:ef:59:74 00:24:e4:ef:39:dc a4:7e:fa:02:4b:93 00:24:e4:ee:d6:87 00:24:e4:ee:ce:f3 a4:7e:fa:02:7f:bf 00:24:e4:d4:0c:f8 00:24:e4:ef:3c:1f 00:24:e4:d4:1d:a4 00:24:e4:ee:bf:ba 00:24:e4:ee:be:ec 00:24:e4:ef:2a:3f 00:24:e4:d4:17:9e 00:24:e4:ef:3f:32 00:24:e4:e6:f1:4a 00:24:e4:ef:2a:d7 00:24:e4:c0:98:8c 00:24:e4:e7:63:d5 00:24:e4:e6:f1:03 00:24:e4:ee:c6:e6 00:24:e4:ee:ae:7b 00:24:e4:d4:04:63 00:24:e4:ef:2b:5e 00:24:e4:e6:ed:f4 00:24:e4:e7:5c:b7 00:24:e4:e6:ca:58 00:24:e4:ef:28:a8 00:24:e4:e7:3f:f4 00:24:e4:c0:4d:7d 00:24:e4:d4:13:ec 00:24:e4:e7:33:24 00:24:e4:e6:81:28 00:24:e4:ef:59:42 00:24:e4:e6:ca:a3 a4:7e:fa:02:39:2e 00:24:e4:e6:85:b8 00:24:e4:d4:10:1d 00:24:e4:ef:5d:a8 00:24:e4:e7:0d:55 00:24:e4:c0:b8:c7 a4:7e:fa:02:a9:d6 00:24:e4:d5:08:a7 00:24:e4:ee:bc:f7 a4:7e:fa:02:ff:77 00:24:e4... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide distribution in the US. No foreign distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 29, 2023
- Recall initiation date
- Dec 19, 2022
- Center classification date
- Mar 22, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.