BEUDAMED
    FDA Enforcement Class II Terminated

    Cardio Vascular-Allura Centron, system code 722400

    Recall: Z-1494-2020 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1494-2020
    Event ID
    84756
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    December 30, 2019
    Classification Date
    March 13, 2020
    Termination Date
    November 17, 2022
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032, United States

    Description

    Cardio Vascular-Allura Centron, system code 722400

    Reason

    A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.

    Code Info

    Not distributed in US. Serial numbers 132 133 49 66 71 135 31 36 79 69 137 149 147 109 136 108 103 93 53 127 129 129 55 74 2 57 106 56 86 68 157 78 64 63 23 51 100 97 102 113 90 44 30 101 77 83 67 151 22 70 96 116 131 35 82 9 91 43 61 161 28 34 27 19 144 92 168 172 173 122 197 139 6 76 176 16 130 60 80 184 112 81 89 42 110 155 33

    Distribution

    Nationwide domestic distribution. Foreign distribution worldwide.

    Quantity

    87