BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

    Recall: Z-2114-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2114-2016
    Event ID
    74511
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 6, 2016
    Initiation Date
    June 21, 2016
    Classification Date
    June 30, 2016
    Termination Date
    July 2, 2018
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

    Reason

    Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.

    Code Info

    901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223

    Distribution

    Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

    Quantity

    14 units