BEUDAMED
    FDA Recall Terminated

    Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.

    Recall: Z-1607-2016 · Initiated April 24, 2016

    Recall

    Recall Number
    Z-1607-2016
    Event Number
    74005
    Firm
    Toshiba American Medical Systems Inc
    FEI Number
    2020563
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 24, 2016
    Posted
    May 4, 2016
    Terminated
    February 22, 2017
    Address
    2441 Michelle Dr PO Box 2068, Tustin, CA, 92780-7047

    Description

    Toshiba American Medical Systems Celesteion, Item Code: PCA-9000A/2, 9000A/3B, 9000A/2B This system is designed to acquire CT images, PET images, and fusion images (superimposed PET and CT images). The images that can be acquired include planar images (for any position and from any direction) and volume images (3D images) of the whole human body (including the head). The CT images provide morphological information showing the positional relationships between the lesion and adjacent tissues, while the PET images provide functional information based on the uptake of the injected radioisotope.

    Reason

    Potential degradation of detector performance.

    Action

    Toshiba sent an Urgent Medical Device Correction letter dated April 24, 2016 to all affected customers. The letter informed customers that Toshiba America Medical Systems is bringing attention to a potential problem with the Celestion PET/CT System. The letter informed the customers of a potential degradation of detector performance and informed the customers of the problems and the corrective actions to be taken. Customers were instructed to complete and return the attached form and fax it to (877) 349-3054 or be sent via email to [email protected]. Customers with questions were instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.

    Distribution

    US Distribution to WI and NV.

    Quantity

    3 units