BEUDAMED
    FDA Enforcement Class II Terminated

    CS-7, Model No. A4C1

    Recall: Z-2281-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2281-2018
    Event ID
    80220
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Konica Minolta Medical Imaging USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    May 9, 2018
    Classification Date
    June 22, 2018
    Termination Date
    April 10, 2020
    Address
    411 Newark Pompton Tpke, Wayne, NJ, 07470-6657, United States

    Description

    CS-7, Model No. A4C1

    Reason

    Panasonic has issued a Mandatory Product Safety Notice, indicating a possibility of battery ignition (fire) in CF-C2 "Toughbook" laptops. Since Konica Minolta uses this laptop in some of its product configurations, it notified its customers to utilize a BIOS Utility for the laptops to minimize the risk of an incident while Panasonic develops a final solution.

    Code Info

    All version numbers.

    Distribution

    Nationwide distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Colombia, Ecuador, Japan, Mexico, Netherlands, and Peru.