Z-0203-2018Class II

Fukuda Denshi patient monitor model DS-8100M and DS-8100N

Name: Z-0203-2018 Fukuda Denshi patient monitor model DS-8100M and DS-8100N
Creator: Fukuda Denshi Co., Ltd.
Published: 2017-10-16
License: https://open.fda.gov/license/

Fukuda Denshi Co., Ltd. / initiated 2017-10-16 / Completed / root cause: design

FDA source

Fukuda Denshi Co., Ltd. began a recall of Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated... on 2017-10-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0203-2018
Classification: Class II
Status: Completed
Initiated: 2017-10-16
Posted: 2017-12-06
Recalling firm: Fukuda Denshi Co., Ltd.
Product: Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: 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).
Root cause tag: design
FDA root cause: Component design/selection
Action: The recalling firm will notify affected consignees via Field Correction Notification letter. The letter identified the affected product, problem and actions to be taken. A Customer Confirmation Sheet to be filled out by end user and faxed or emailed back to Fukuda Denshi USA, Inc will also be included. For questions call 206-305-4460.
Quantity in commerce: 6227 units
Distribution: Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries
Product codes and lots: all DS-8100 units manufactured and distributed worldwide.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0203-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0203-2018	Class II	Completed	Voluntary: Firm initiated	2017-12-13	2017-12-06

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)