Fukuda Denshi DS-8100M/N Patient Monitor Recall: Short-Term Battery Error Risk
Fukuda Denshi recalls DS-8100M and DS-8100N patient monitors with a rare short-term battery error due to damaged lithium-ion capacitors. Affected units may display error messages and require replacement.
Lower-risk 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).
Contact the company
What happened, in plain English
Fukuda Denshi is recalling its DS-8100M and DS-8100N patient monitors because a small percentage of units have a damaged lithium-ion battery backup that can cause short-term error messages. This issue is rare but could lead to inaccurate monitoring readings if the error message appears. Read more at govinfonow.com/recall/72837-fukuda-denshi-ds-8100m-n-patient-monitor-recall-short-term.
Source Summary by GovInfoNow · govinfonow.com/recall/72837-fukuda-denshi-ds-8100m-n-patient-monitor-recall-short-term · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0203-2018
Cite this page
“Fukuda Denshi DS-8100M/N Patient Monitor Recall: Short-Term Battery Error Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72837-fukuda-denshi-ds-8100m-n-patient-monitor-recall-short-term. Based on FDA recall #Z-0203-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0203-2018%22&limit=1).
Why it’s dangerous
In less than 0.003% of units, a damaged lithium-ion battery backup causes a short-term error message. This may lead to inaccurate monitoring readings but does not cause physical harm or device failure in normal use.
Who’s affected
Healthcare providers using the DS-8100M or DS-8100N patient monitors worldwide. Patients receiving monitoring from these devices are at low risk since the error is rare and does not cause immediate harm.
How to tell if you have this one
Check for the DS-8100M or DS-8100N model numbers on the device. The recall applies to all units sold worldwide since the product's launch.
- Brand
Fukuda Denshi- Category
Medical device
What to do — step by step
Check for Error Message
Look for a short-term battery error message on the monitor display.
Contact Manufacturer
Reach out to Fukuda Denshi for guidance on next steps if the error message appears.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - US Nationwide and in the countries of UK, and Japan and via distributors in the other countries” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 58 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0203-2018 (October 16, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0203-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.