Facility

KONICA MINOLTA, INC.

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

Key facts

1recalls · worst Class II

1inspections · 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)	3003769120
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	2970 ISHIKAWA-MACHI HACHIOJI-SHI Tokyo, JP 19285
Registration status	Active · expires 2026
Parent company	KONICA MINOLTA, INC. (owner-operator 9009884)
Brand names	SKR 4000; P-41

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Solid State X-Ray Imager (Flat Panel/Digital Imager)
Product code MQB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680

Recalls & enforcement

Class IITerminated2017-04-24
The Doppler velocity measurement on the Sonimage HS1 ultrasound system is not accurate.

FDA inspections (1)

VAI2023-04-05
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted

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. “KONICA MINOLTA, INC. (FEI 3003769120) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003769120-konica-minolta-inc/

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