BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System

    Recall: Z-1713-2016 · Reported June 15, 2016

    Enforcement

    Recall Number
    Z-1713-2016
    Event ID
    74149
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 15, 2016
    Initiation Date
    September 6, 2015
    Classification Date
    June 6, 2016
    Termination Date
    March 4, 2021
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips Healthcare Brilliance 64 Computed Tomography X-Ray System

    Reason

    Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm

    Code Info

    Software v. 4.13, 4.14 and 4.15.

    Distribution

    US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.

    Quantity

    US - 423