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Terminated

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.

FDA Recall Z-0661-2016 · Posted 2016-01-16

Recalling FirmFukuda Denshi USA, Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2015-12-21
Date Terminated2016-08-19
Product Quantity95 units distributed in the US

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).

Firm Action

Fukuda Denshi USA, Inc. of Redmond, WA plans to perform 100% field correction of units distributed in the US. The Recall/Field Correction Notice letter (FCN-A01-201512), dated December 21, 2015, and the Customer Confirmation Sheet will be sent to consignees using a clearly red-marked URGENT via Express Mail. The consignees are requested to fill out the Customer Confirmation Sheet and return via fax to 888-224-7090, email to [email protected], or send via postal service back to Fukuda Denshi USA, Inc. in a pre-stamped envelope. Consignee can call Doug Blakey directly at 210-240-4521 with any questions or concerns.

Root Cause

Process control

Distribution Pattern

Distributed in the states of CO, ID, KS, MI, MO, OR, PA, TX, UT, and WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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