Facility

Withings

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008820594
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	2 rue Maurice Hartmann Issy-les-Moulineaux Ile-de-France, FR 92130
Registration status	Active · expires 2026
Parent company	Withings (France) (owner-operator 10035674)
Brand names	Scan Monitor (ScanWatch, HWA09); Scan Monitor (ScanWatch 2, HWA10)

Activity by year

Recalls (2)

Devices registered here (3)

Transmitters And Receivers, Electrocardiograph, Telephone
Product code DXH (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2920
Oximeter
Product code DQA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700
Electrocardiograph
Product code DPS (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2340

Recalls & enforcement

Class IIOngoing2022-12-19
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.
Class IICompleted2018-06-11
Device could not meet the requirements for systolic pressure

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Withings (FEI 3008820594) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008820594-withings/

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