Z-0661-2016Class II

Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M...

Name: Z-0661-2016 Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M...
Creator: Fukuda Denshi USA, Inc.
Published: 2015-12-21
License: https://open.fda.gov/license/

Fukuda Denshi USA, Inc. / initiated 2015-12-21 / Terminated / root cause: manufacturing process

FDA source

Fukuda Denshi USA, Inc. began a recall of 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... on 2015-12-21. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0661-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Posted: 2016-01-16
Terminated: 2016-08-19
Recalling firm: Fukuda Denshi USA, Inc.
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.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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).
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Fukuda Denshi USA, Inc. of Redmond, WA plans to perform 100% field correction of units distributed in the US. The Recall/Field Correction Notice letter (FCN-A01-201512), dated December 21, 2015, and the Customer Confirmation Sheet will be sent to consignees using a clearly red-marked URGENT via Express Mail. The consignees are requested to fill out the Customer Confirmation Sheet and return via fax to 888-224-7090, email to [email protected], or send via postal service back to Fukuda Denshi USA, Inc. in a pre-stamped envelope. Consignee can call Doug Blakey directly at 210-240-4521 with any questions or concerns.
Quantity in commerce: 95 units distributed in the US
Distribution: Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0661-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0661-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-15

Product code MHX

K134046Class IIFukuda Denshi Dynascope Model Ds-8100N/8100m Patient MonitorFukuda Denshi USA, Inc. / cleared 2015-02-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)