Facility

FUKUDA DENSHI CO., LTD.

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

Key facts

2recalls · worst Class II

2inspections · worst VAI

—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)	3002807019
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	3-39-4 Hongo Bunkyo-ku Tokyo, JP 11384
Registration status	Active · expires 2026
Parent company	Fukuda Denshi Co., Ltd. (owner-operator 9028352)
Brand names	Fukuda Denshi 4000 Series ECG

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

(unnamed device)
Product code LOS (opens in a new tab)

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 (2)

NAI2025-04-10
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-08-02
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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 CO., LTD. (FEI 3002807019) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002807019-fukuda-denshi-co-ltd/

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