BEUDAMED
    FDA Enforcement Class II Terminated

    Brilliance iCT Computed Tomography X-ray system

    Recall: Z-0545-2016 · Reported December 30, 2015

    Enforcement

    Recall Number
    Z-0545-2016
    Event ID
    72684
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Medical Systems (Cleveland) Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2015
    Initiation Date
    October 29, 2015
    Classification Date
    December 24, 2015
    Termination Date
    June 26, 2018
    Address
    595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States

    Description

    Brilliance iCT Computed Tomography X-ray system

    Reason

    Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.

    Code Info

    Model No. 728306; S/N: 85015, 85021, 85028, 85034, 85036, 85039, 85042, 85047, 85051, 100030, 100038, 100040, 100051, 100054, 100058, 100065, 100072, 100093, 100094, 100099, 100101, 100140, 100144, 100162, 100181, 100190, 100214, 100217, 100228, 100236, 100244, 100278, 100421, 100462, 100472, 100613, 100616, 100624, 100627, 100628, 100632, 100639, 100640, 100641, 100644, 100647, 100651, 100654, 100655, 100659, 100660, 100662, 100667 & 100669.

    Distribution

    Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

    Quantity

    51 Units