BEUDAMED
    FDA Recall Terminated

    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the

    Recall: Z-0236-2015 · Initiated July 31, 2014

    Recall

    Recall Number
    Z-0236-2015
    Event Number
    69356
    Firm
    Philips Medical Systems, Inc.
    FEI Number
    1218950
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    July 31, 2014
    Posted
    December 16, 2014
    Terminated
    February 16, 2017
    Address
    3000 Minuteman Rd, Andover, MA, 01810-1032

    Description

    Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. (d) A description of the defect in the

    Reason

    It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location.

    Action

    Philips Healthcare is directly notifying affected users via letter. In addition, Philips Healthcare has performed the software correction for forward production and plans a Field Correction to fix the defect in the field. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office.

    Distribution

    US Distribution

    Quantity

    16 systems