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Recall Observatory FDA recall evidence

Device product

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.

Z-0661-2016

December 21, 2015

Class II

Product summary

Firm
Fukuda Denshi USA, Inc.
Event
Event 72953
Status
Terminated
Classification
Class II
Quantity
95 units distributed in the US
Official record key
device-enforcement:Z-0661-2016

Official wording

Reason: 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).

Code information: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).