BEUDAMED
    FDA Enforcement Class II Terminated

    C3 Wave App, v. 2.0.5

    Recall: Z-0222-2020 · Reported November 6, 2019

    Enforcement

    Recall Number
    Z-0222-2020
    Event ID
    81439
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 6, 2019
    Initiation Date
    October 1, 2018
    Classification Date
    October 25, 2019
    Termination Date
    October 1, 2020
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936, United States

    Description

    C3 Wave App, v. 2.0.5

    Reason

    When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be completed without using alternate methods to confirm PICC tip placement.

    Code Info

    v. 2.0.5; all units

    Distribution

    Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada, Croatia, Czech Republic, Great Britain, Greece, Italy, Netherlands, Slovenia, and Sweden.

    Quantity

    24