CLASS II Device recall · Reported 27 Jan 2016 · FDA Enforcement Report

Fukuda Denshi patient monitor recalled

Fukuda Denshi USA is recalling Fukuda Denshi patient monitor, distributed in 10 states. The recall was initiated on 21 Dec 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes50400001, 50400002, 50400003, 50400004, 50400011, 50400012, 50400018, 50400019, 50400020, 50400021, 50400022, 50400023, 50400024, 50400025, 50400026, 50400027, 50400028, 50400029, 50400030, 50400031, 50400032, 50400033, 50400034, 50400035, 50400036, 50400037, 50400038, 50400039, 50400040, 50400042, 50400043, 50400044, 50400045, 50400046, 50400047, 50400048, 50400049, 50400050, 50400051, 50400052, 50400053, 50400054, 50400055, 50400056, 50400057, 50400058, 50400059, 50400060, 50400061, 50400062, 50400063, 50400064, 50400065, 50400066, 50400067, 50400068, 50400069, 50400070, 50400071, 50400072, 50400073, 50400074, 50400075, 50400076, 50400077, 50400078, 50400084, 50400093, 50400094, 50400095, 50400096, 50400097, 50400098, 50400099, 50400100, 50400101, 50400102, 50400103, 50400104, 50400105, 50400106, 50400107, 50400108, 50400109, 50400110, 50400111, 50400112, 50400113, 50400114, 50400115, 50400116, 50400117, 50400118, 50400119, and 50400120.

Quantity recalled95 units distributed in the US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0661-2016
FDA event ID: 72953
Recalling firm: Fukuda Denshi USA, Redmond, WA
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2015
FDA classified: 15 Jan 2016
Reported: 27 Jan 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Patient Monitors

Timeline

21 Dec 2015	Recall initiated by company
15 Jan 2016	Classified by FDA	+25 days
27 Jan 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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).

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.

Where it was distributed

Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.

Colorado Idaho Kansas Michigan Missouri Oregon Pennsylvania Texas Utah Wisconsin

Questions about this recall

Why was it recalled?

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).

Which lots are affected?

50400001, 50400002, 50400003, 50400004, 50400011, 50400012, 50400018, 50400019, 50400020, 50400021, 50400022, 50400023, 50400024, 50400025, 50400026, 50400027, 50400028, 50400029, 50400030, 50400031, 50400032, 50400033, 50400034, 50400035, 50400036, 50400037, 50400038, 50400039, 50400040, 50400042, 50400043, 50400044, 50400045, 50400046, 50400047, 50400048, 50400049, 50400050, 50400051, 50400052, 50400053, 50400054, 50400055, 50400056, 50400057, 50400058, 50400059, 50400060, 50400061, 50400062, 50400063, 50400064, 50400065, 50400066, 50400067, 50400068, 50400069, 50400070, 50400071, 50400072, 50400073, 50400074, 50400075, 50400076, 50400077, 50400078, 50400084, 50400093, 50400094, 50400095, 50400096, 50400097, 50400098, 50400099, 50400100, 50400101, 50400102, 50400103, 50400104, 50400105, 50400106, 50400107, 50400108, 50400109, 50400110, 50400111, 50400112, 50400113, 50400114, 50400115, 50400116, 50400117, 50400118, 50400119, and 50400120.

Where was it sold?

Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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