Fukuda Denshi Patient Monitor Recall for Damaged Lithium-Ion Capacitor
Fukuda Denshi is recalling DS-8100M and DS-8100N patient monitors because a damaged lithium-ion capacitor may cause a short-term battery error message.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a battery error message in a very small percentage of devices (17 out of 6,227) with no reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Fukuda Denshi Co., Ltd. is recalling 6,227 units of the DynaScope Model DS-8100M and DS-8100N patient monitors. These devices are used to observe physiological parameters such as ECG, respiration, blood pressure, and oxygen saturation in adult, pediatric, and neonatal patients.
The recall is due to a damaged lithium-ion capacitor, which serves as the short-term battery backup. In less than 0.003% of the devices sold worldwide (17 units), a 'Short-term Battery Error' message has appeared. The issue has been traced to this specific component failure.
The affected units were distributed worldwide, including the US, UK, and Japan, as well as other countries via distributors. Users should contact Fukuda Denshi for instructions on how to address the issue.
The recalled product
- 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…
- Manufacturer
- Fukuda Denshi Co., Ltd.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 6,227
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all DS-8100 units manufactured and distributed worldwide.
Distribution
Distributed nationwide across the United States.
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