# FDA recall Z-0203-2018

> **Fukuda Denshi Co., Ltd.** · Class II · device recall initiated 2017-10-16.

## 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 parame

## 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).

## Distribution

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

## Key facts

- **Recall number:** Z-0203-2018
- **Recalling firm:** Fukuda Denshi Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2017-10-16
- **Report date:** 2017-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tokyo, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2018

## Citation

> AI Analytics. FDA recall Z-0203-2018. Retrieved 2026-07-04 from https://api.ai-analytics.org/recall/Z-0203-2018. Source: US FDA. Licensed CC0.

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