Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 27, 2016
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.
A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fukuda Denshi USA, Inc. recalled Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope… - a moderate-severity action.
Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope… was recalled by Fukuda Denshi USA, Inc. in January 27, 2016. Reason: A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a ba…. Check the official notice for the remedy. Verify recall #Z-0661-2016 with the FDA Devices before acting.
The recall
Fukuda Denshi USA, Inc. issued this moderate-severity FDA Devices recall-A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a ba….
- Moderate
- severity level
- 95 units
- affected scope
- Class II
- classification
- January 27, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0661-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0661-2016) was formally reported on January 27, 2016, with the manufacturer initiating the action on December 21, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Fukuda Denshi USA, Inc. is listed as the recalling firm, operating out of Redmond, WA. Federal records list the affected scope as 95 units distributed in the US.
The documented reason for this recall is: A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery). Distribution data in the federal record shows the product reached: Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.. 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.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
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.
Affected scope
95 units distributed in the US
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0661-2016 |
| Date reported | January 27, 2016 |
| Date initiated | December 21, 2015 |
| Recalling firm | Fukuda Denshi USA, Inc. |
| Firm location | Redmond, WA |
| Affected scope | 95 units distributed in the US |
| Distribution | Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0661-2016) 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? ▼
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.. Recalled by Fukuda Denshi USA, Inc.. Units affected: 95 units distributed in the US.
Why was this product recalled? ▼
A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 27, 2016. Severity: Moderate. Recall number: Z-0661-2016.
Where was the recalled product distributed? ▼
Distribution: Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0661-2016) 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 January 27, 2016. 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.