--- title: "Scan Monitor/ScanWatch, model number hwa09 Wearable, Bluetooth-connected wris... — FDA record Z-1280-2023 | Is It on Recall" description: "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 ph" url: https://isitonrecall.com/recall/fda-device-z-1280-2023-scan-monitor-scanwatch-model-number-hwa09-wearable-bluetooth-connected-wrist-watch-that-records-hear/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## 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 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1280-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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 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00:24:e4:d3:ea:36 00:24:e4:d4:05:f2 00:24:e4:ef:45:f0 00:24:e4:b1:60:1a 00:24:e4:ef:36:7d 00:24:e4:e7:51:e6 00:24:e4:d4:1f:6f 00:24:e4:d4:17:a5 00:24:e4:c0:90:45 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](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1280-2023%22). 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](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/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. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1280-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Withings records](https://isitonrecall.com/brand/withings/)