Facility

ECHONOUS, INC.

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

Key facts

1recalls · 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)	3013757696
Establishment type	Manufacture Medical Device
Location	8310 154th Ave NE Redmond, WA, US 98052
Registration status	Active · expires 2026
Parent company	ECHONOUS, INC. (owner-operator 10055454)

Activity by year

Recalls (1)

Devices registered here (1)

System, Digital Image Communications, Radiological
Product code LMD (opens in a new tab) · Class I · Radiology · 21 CFR 892.2020

Recalls & enforcement

Class IIOngoing2024-05-09
Ultrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party software, such as PACS or other post-processing software, which may lead to inaccurate diagnoses or treatment.

All facilities operated by ECHONOUS, INC.

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. “ECHONOUS, INC. (FEI 3013757696) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013757696-echonous-inc/

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