Facility

Fukuda Denshi Finetech Sendai Co., Ltd.

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)	3010663777
Establishment type	Manufacture Medical Device
Location	5, Technohills, Taiwacho Kurokawa-gun Miyagi, JP 98136
Registration status	Active · expires 2026
Parent company	Fukuda Denshi Co., Ltd. (owner-operator 9028352)
Brand names	Sigma 5000 Series Ultrasound

Activity by year

Recalls (2)

Devices registered here (3)

System, Imaging, Pulsed Doppler, Ultrasonic
Product code IYN (opens in a new tab) · Class II · Radiology · 21 CFR 892.1550
Transducer, Ultrasonic, Diagnostic
Product code ITX (opens in a new tab) · Class II · Radiology · 21 CFR 892.1570
System, Imaging, Pulsed Echo, Ultrasonic
Product code IYO (opens in a new tab) · Class II · Radiology · 21 CFR 892.1560

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).

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 Finetech Sendai Co., Ltd. (FEI 3010663777) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010663777-fukuda-denshi-finetech-sendai-co-ltd/

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