BEUDAMED
    FDA Enforcement Class II Terminated

    Ingenuity Core128/Elite China 728324

    Recall: Z-2277-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2277-2018
    Event ID
    80176
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    March 28, 2018
    Classification Date
    June 22, 2018
    Termination Date
    April 21, 2020
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131, United States

    Description

    Ingenuity Core128/Elite China 728324

    Reason

    A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.

    Code Info

    UDI: (01)00884838059863(21)336856, Serial Number: 336856; UDI: (01)00884838059863(21)336851, Serial Number: 336851; UDI: (01)00884838059863(21)336849, Serial Number: 336849; UDI: (01)00884838059863(21)336852, Serial Number: 336852; UDI: (01)00884838059863(21)336853, Serial Number: 336853; UDI: (01)00884838059863(21)336855, Serial Number: 336855; UDI: (01)00884838059863(21)336854, Serial Number: 336854; UDI: (01)00884838059863(21)336850, Serial Number: 336850

    Distribution

    The systems were distributed to the following US states: HI, KS, and MO. The systems were distributed to the following foreign countries: Algeria, Austria, Brazil, China, Indonesia, Japan, Kenya, Korea, Mexico, Poland, Turkey, and Uganda.