BEUDAMED
    FDA Enforcement Class II Terminated

    Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.

    Recall: Z-0033-2014 · Reported October 30, 2013

    Enforcement

    Recall Number
    Z-0033-2014
    Event ID
    66312
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 30, 2013
    Initiation Date
    August 7, 2013
    Classification Date
    October 21, 2013
    Termination Date
    March 26, 2014
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.

    Reason

    There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.

    Code Info

    M/N: 781220, 781230, 781301, 78129 and 78127. Codes: AM128, 1510, 1518, BA318, AM120, ZA178, ZA196, ZA107, ZA133, ZA172, ZA158, BA149 and ZA208.

    Distribution

    Worldwide Distribution - US (nationwide) including FL, CO, KY, MS, PA, NC, NJ, TX and Puerto Rico and internationally to Italy.

    Quantity

    Total 511 (Asset 0.5T,: 35 units Apollo 0.5T: 15 units, Infinion 1.5T: 116 units, Eclipse/Polaris 1.5T: 290 units, Panorama 0.6T: 55 units)