BEUDAMED
    FDA Recall 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.

    Recall: Z-0661-2016 · Initiated December 21, 2015

    Recall

    Recall Number
    Z-0661-2016
    Event Number
    72953
    Firm
    Fukuda Denshi USA, Inc.
    FEI Number
    3000215024
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 21, 2015
    Posted
    January 16, 2016
    Terminated
    August 19, 2016
    Address
    17725 NE 65th St, Ste C, Redmond, WA, 98052-4911

    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

    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).

    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.

    Distribution

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

    Quantity

    95 units distributed in the US