{"id":"c1338c72-2cea-4c24-b96a-920016a82e01","slug":"withings-scanwatch-ecg-recall-2022","kind":"recall","headline":"Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review","summary":"An iOS app bug (occurred Oct 4 2022) bypassed the K201456-required initial physician-supervised ECG activation/review on the ScanWatch; Withings initiated a recall Dec 19 2022 and the FDA classified it Class 2 on Mar 22 2023. About 1,500 US users were affected; fixed via a Withings app update (v5.14+). A correctable software defect (off-label use of the cleared ECG feature), no injury.","occurredAt":"2022-12-19T12:00:00.000Z","reviewStatus":"reviewed","modelId":"7b714434-e448-4dd4-8302-98627a94db3b","deploymentId":null,"companyId":null,"aliases":[],"collisionRisk":"none","reviewNote":null,"severity":"moderate","rootCauseCategory":"software_defect","rootCauseDetail":"iOS app bug bypassed the cleared-ECG physician-review gate; ~1,500 US users; remediated by app update.","affectedUnitsCount":1500,"affectedUnitsBasis":"exact","remediationStatus":"remediated","regulatoryAction":"recall_ordered","regulatoryBody":"FDA","createdAt":"2026-06-04T20:25:18.082Z","updatedAt":"2026-06-04T20:25:18.082Z","model":{"id":"7b714434-e448-4dd4-8302-98627a94db3b","companyId":"949b1fd6-4daa-4efb-9449-ac8c07c5c2d5","modelName":"Withings ScanWatch","slug":"withings-scanwatch","description":"Withings, a French consumer-health-electronics company founded in 2008 and independent again since 2018 after being bought back from Nokia, makes the ScanWatch line of biometric-primary hybrid analog smartwatches with cardiac and respiratory AI augmentation, recorded in the new biometric form factor. The ScanWatch 2 and ScanWatch Nova pair an analog dial with optical heart-rate, electrical ECG, blood-oxygen, and continuous temperature sensors on roughly a 30-day battery. Their FDA clearances are the ECG app, cleared in October 2021 to classify atrial fibrillation, sinus rhythm, and high heart rate for adults 22 and older, updated in July 2025 so that the ScanWatch 2 ECG is cleared over the counter, no longer requiring a board-certified cardiologist to activate, with a new eight-classification atrial-fibrillation algorithm, plus a cleared blood-oxygen feature that supports tracking breathing disturbances at night. A cap-flag applies because the breathing-disturbance detection is a screening aid rather than a sleep-apnea diagnosis, and framing it as diagnosis exceeds scope. Withings offers a clean contrast to Apple, since its blood-oxygen and ECG features were never disabled in the US as it is not party to the Masimo dispute, and the notable 2025 regulatory event was a positive over-the-counter liberalization rather than a restriction. It sells by hardware purchase with an optional Withings+ membership, its clinical-validation posture is substantial for its size with strong study framing and CE medical marking, and the exact clearance numbers and dates for the ScanWatch 2 blood-oxygen and temperature features and the standard US list prices are approximate and not fully verified.","formFactor":"biometric","maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{"notes":[{"label":"FDA clearances","value":"ECG app: FDA-cleared Oct 2021 (single-channel; classifies AFib/sinus rhythm/high HR; adults 22+). July 2025 update: ScanWatch 2 ECG cleared OTC - US users no longer need a board-certified cardiologist to activate ECG; new AFib algorithm gives 8 classifications (up from 4). SpO2: FDA-cleared (supports tracking blood-oxygen + breathing disturbances at night)."},{"label":"CAP-FLAG + clean contrast","value":"'Breathing disturbances detection' is a SCREENING AID, not a sleep-apnea DIAGNOSIS - framing it as apnea diagnosis exceeds scope. Clean contrast to Apple: Withings' SpO2/ECG were NEVER disabled in the US (not party to the Masimo dispute); the notable 2025 regulatory event was a POSITIVE OTC liberalization, not a restriction."},{"label":"Verification posture","value":"Boundary: biometric-primary + AI-augmented. Clinical posture: SUBSTANTIAL-for-size (strong clinical-study framing; multiple ScanWatch SpO2/apnea validation studies; CE medical marking). NOT verified: exact K-numbers/dates for ScanWatch 2 SpO2 + temperature clearances (K240795/K240909 seen but date-to-feature mapping not fully nailed); standard ScanWatch Nova + ScanWatch 2 US list prices (approximate)."}],"specs":"ScanWatch 2 (~$349) + ScanWatch Nova (Nova Brilliant $599.95, Nov 2024). Hybrid analog-dial + sensor watches: PPG optical HR, electrical ECG, SpO2, TempTech24/7 continuous temperature; ~30-day battery. AI/health: ECG (AFib/sinus/high-HR), SpO2 + breathing-disturbance detection, temperature trends. Founded 2008, France (Issy-les-Moulineaux); independent since 2018 (bought back from Nokia). Hardware purchase; Withings+ ($9.95/mo) optional.","formFactor":"biometric (biometric-primary hybrid analog smartwatch + AI; ECG/SpO2 cleared)"},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://en.wikipedia.org/wiki/Withings","title":"Withings (French; founded 2008; hybrid analog+sensor health watches; independent since 2018)","sourceName":"Wikipedia"},{"url":"https://support.withings.com/hc/en-us/articles/16780197080209-ScanWatch-2-ECG-Frequently-Asked-Questions-FAQ-U-S-Only","title":"Withings ScanWatch 2 ECG (FDA-cleared; AFib/sinus/high-HR; adults 22+)","sourceName":"Withings (official)"},{"url":"https://support.withings.com/hc/en-us/articles/36773695647249-ScanWatch-2-ECG-Update-2025-U-S","title":"Withings ScanWatch 2 ECG update (Jul 2025: cleared OTC, no cardiologist needed; new 8-class AFib algo)","sourceName":"Withings (official)"},{"url":"https://sleepreviewmag.com/sleep-diagnostics/consumer-sleep-tracking/wearable-sleep-trackers/fda-clears-withings-scanwatch-spo2/","title":"FDA clears Withings ScanWatch SpO2 (tracks breathing disturbances at night - screening aid)","sourceName":"Sleep Review"},{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201456","title":"Withings ScanWatch (Scan Monitor) 510(k) K201456 (Oct 5 2021; single clearance covering BOTH ECG/AFib and SpO2/blood-oxygen)","sourceName":"FDA 510(k)/De Novo Database"},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC8078374/","title":"Validation of the Withings ScanWatch as a wrist reflective pulse oximeter (JMIR 2021; PMID 33857011)","sourceName":"Journal of Medical Internet Research"}],"aliases":["Withings ScanWatch","ScanWatch 2","ScanWatch Nova"],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"createdAt":"2026-06-03T22:31:38.802Z","updatedAt":"2026-06-04T17:56:06.990Z"},"deployment":null,"company":null,"derived":{"status":"active"},"sources":[{"id":"edbd6dbd-f259-4df1-89a4-126f1dbdc743","incidentId":"c1338c72-2cea-4c24-b96a-920016a82e01","url":"https://gadgetsandwearables.com/2023/03/23/withings-scanwatch-recall-ecg-issue/","label":"Gadgets & Wearables","publishedAt":null,"notes":null,"title":null,"sourceName":null,"mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-06-04T20:25:18.082Z","updatedAt":"2026-06-04T20:25:18.082Z"},{"id":"28c95e52-baf6-43a6-97db-ba22b6ab7b70","incidentId":"c1338c72-2cea-4c24-b96a-920016a82e01","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=198114","label":"FDA (recall record)","publishedAt":null,"notes":null,"title":null,"sourceName":null,"mediaType":"article","videoId":null,"channel":null,"durationSec":null,"timestampSec":null,"createdAt":"2026-06-04T20:25:18.082Z","updatedAt":"2026-06-04T20:25:18.082Z"}],"responses":[],"statusEvents":[],"jsonLd":{"@context":"https://schema.org","@type":"NewsArticle","@id":"https://registry.deploy.report/incidents/withings-scanwatch-ecg-recall-2022","url":"https://registry.deploy.report/incidents/withings-scanwatch-ecg-recall-2022","headline":"Withings ScanWatch FDA Class 2 recall: app bug let users run ECG without physician review","description":"An iOS app bug (occurred Oct 4 2022) bypassed the K201456-required initial physician-supervised ECG activation/review on the ScanWatch; Withings initiated a recall Dec 19 2022 and the FDA classified it Class 2 on Mar 22 2023. About 1,500 US users were affected; fixed via a Withings app update (v5.14+). A correctable software defect (off-label use of the cleared ECG feature), no injury.","identifier":"c1338c72-2cea-4c24-b96a-920016a82e01","datePublished":"2022-12-19T12:00:00.000Z","articleSection":"recall","publisher":{"@id":"https://deploy.report/#organization"},"author":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":2,"primary_source_types":["primary-fda-database"]}}}