BEUDAMED
    FDA Recall Terminated

    Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.

    Recall: Z-1549-2013 · Initiated February 22, 2013

    Recall

    Recall Number
    Z-1549-2013
    Event Number
    33728
    Firm
    Aperio Technologies Inc
    FEI Number
    3006791373
    Product Code
    IBM
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    February 22, 2013
    Posted
    June 17, 2013
    Terminated
    September 25, 2013
    Address
    1360 Park Center DR, Vista, CA, 92081-8300

    Description

    Aperio ScanScope System. Aperio ScanScope Models, XT, AT, AT Turbo, CS and CSO. Automated digital slide creation and viewing device. It is intended to create and view electronic image files representative of tissue specimens fixed to glass slides.

    Reason

    Aperio initiated this recall because the User Guides incorrectly state the devices had been cleared for specific applications. The User Guides should state the devices are for Research Use Only and are not for use in diagnostic procedures.

    Action

    Aperio sent an Urgent Medical Device Recall letter dated April 22, 2013 to all affected consignees via certified USPS mail. The letter included the reason for the recall, recall product information, instructions, acknowledgement form, contact information ( Aperio Technical Support at 1-866-478-3999), and product labeling. The consignees were requested to acknowledge receipt of the Medical Device Correction letter. In addition, an Acknowledgement Form is required to be signed and e-mailed back to the Manufacturer as evidence of letter receipt. For questions regarding this recall call 760-304-6211, ext 6211.

    Distribution

    Nationwide Distribution - including all states, none internationally .

    Quantity

    364