Fukuda Denshi Patient Monitors Recalled for Battery Malfunction
Fukuda Denshi is recalling 95 DynaScope patient monitors in the US due to a potential short-term battery error caused by a damaged Lithium-Ion capacitor.
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, and the source text describes a potential malfunction without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Fukuda Denshi USA, Inc. is recalling 95 units of the DynaScope Model DS-8100N and DS-8100M patient monitors in the United States. These devices are used to acquire and monitor physiological signals from patients.
The recall is due to a possible malfunction where a Short-term Battery Error message may appear. This issue has been traced back to a bad or damaged Lithium-Ion capacitor, which serves as the short-term backup battery.
The affected units were distributed in the states of Colorado, Idaho, Kansas, Michigan, Missouri, Oregon, Pennsylvania, Texas, Utah, and Wisconsin. Consumers and healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice and contact the manufacturer for instructions on how to proceed.
The recalled product
- 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.
- Manufacturer
- Fukuda Denshi USA, Inc.
- Category
- Medical Device — Patient Monitor
- Hazard
- Affected units
- 95
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 (20)
- 50400001
- 50400002
- 50400003
- 50400004
- 50400011
- 50400012
- 50400018
- 50400019
- 50400020
- 50400021
- 50400022
- 50400023
- 50400024
- 50400025
- 50400026
- 50400027
- 50400028
- 50400029
- 50400030
- 50400031
Distribution
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