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.

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 indicate 95 units distributed in the US units are affected.

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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.