RegWardenFDA facility compliance records
Facility

FUKUDA DENSHI CO., LTD.

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

Activity by year

FDA actions on record by year2015: 1 recalls; 2017: 1 recalls12015201612017201820192020202120222023202420252026
  • Recalls (2)

Devices registered here (1)

  • Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
    Product code MHX (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).

Related

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 3009607734) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009607734-fukuda-denshi-co-ltd/

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