ModerateClass IICompleted

FDA Devices recall · Reported December 13, 2017

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 s

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0203-2018.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries.

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0203-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 tr…

Recall #: Z-0203-2018
Affected scope: 6227 units
Initiated: October 16, 2017

Compiled from official public sources by the editorial team. · Updated July 2026

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Fukuda Denshi Co., Ltd. recalled Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the F… - a moderate-severity action.

Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the F… was recalled by Fukuda Denshi Co., Ltd. in December 13, 2017. Reason: For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldw…. Check the official notice for the remedy. Verify recall #Z-0203-2018 with the FDA Devices before acting.

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The recall

Fukuda Denshi Co., Ltd. issued this moderate-severity FDA Devices recall-For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldw….

Moderate
severity level: 6K units
affected scope: Class II
classification: December 13, 2017
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0203-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0203-2018) was formally reported on December 13, 2017, with the manufacturer initiating the action on October 16, 2017. It is classified under Moderate severity (Class II), with a current status of Completed. Fukuda Denshi Co., Ltd. is listed as the recalling firm, operating out of Tokyo, N/A. Federal records list the affected scope as 6227 units.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

6227 units

Related Recalls

3 from same agency

Product description

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.

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).

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Completed
Recall number	Z-0203-2018
Date reported	December 13, 2017
Date initiated	October 16, 2017
Recalling firm	Fukuda Denshi Co., Ltd.
Firm location	Tokyo, N/A
Affected scope	6227 units
Distribution	Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

6227 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0203-2018) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0203-2018.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries.

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0203-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 13, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.