BEUDAMED
    FDA Recall Terminated

    ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL

    Recall: Z-0674-03 · Initiated March 4, 2003

    Recall

    Recall Number
    Z-0674-03
    Event Number
    25710
    Firm
    Cti Pet Systems Inc
    FEI Number
    1034973
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 4, 2003
    Posted
    March 21, 2003
    Terminated
    February 7, 2006
    Address
    810 Innovation Drive, Knoxville, TN, 37932-2571

    Description

    ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems: Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan Hitachi Models: Sceptre and Sceptre XL

    Reason

    Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.

    Action

    Written notification was sent via letter with corrective software beginning on March 4 to the end users.

    Distribution

    Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland Netherlands, Austria, France, Turkey, Spain, Sweden, Korea, Saudi Arabia, Russia, PROC (China), Czech Republic, Denmark, Mexico, Slovakia, and Chile

    Quantity

    444