BEUDAMED
    FDA Enforcement Class II Terminated

    Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.

    Recall: Z-1463-2015 · Reported April 29, 2015

    Enforcement

    Recall Number
    Z-1463-2015
    Event ID
    69996
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thermedx LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 29, 2015
    Initiation Date
    September 1, 2014
    Classification Date
    April 20, 2015
    Termination Date
    September 14, 2015
    Address
    31200 Solon Rd, Unit 1, Solon, OH, 44139-3556, United States

    Description

    Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures.

    Reason

    To correct software bugs that could affect the ability to accurately measure fluid deficit.

    Code Info

    Serial Numbers 20100001 through 20140044

    Distribution

    US Distribution to the states of : OH, MS, MA, WA, MI, NC, NY, WV, LA, TX and IL.

    Quantity

    127 units