Facility

FUKUDA DENSHI USA, INC.

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

Key facts

2recalls · worst Class II

1inspections · worst NAI

—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)	3000215024
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	17725 N.E. 65TH ST., BLDG. C REDMOND, WA, US 98052
Registration status	Active · expires 2026
Parent company	Fukuda Denshi Co., Ltd. (owner-operator 9028352)
Brand names	DynaScope DS-5000 Series Central Station

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Detector And Alarm, Arrhythmia
Product code DSI (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1025

Recalls & enforcement

Class IICompleted2017-10-16
For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup).
Class IITerminated2015-12-21
A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).

FDA inspections (1)

NAI2024-03-26
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “FUKUDA DENSHI USA, INC. (FEI 3000215024) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000215024-fukuda-denshi-usa-inc/

Not open yet

Alerts for FUKUDA DENSHI USA, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.