BEUDAMED
    FDA Recall Terminated

    Ingenuity TF PET/CT. Diagnostic imaging system

    Recall: Z-0897-2013 · Initiated January 21, 2013

    Recall

    Recall Number
    Z-0897-2013
    Event Number
    64403
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    KPS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 21, 2013
    Posted
    February 28, 2013
    Terminated
    July 19, 2013
    Address
    595 Miner Rd, Cleveland, OH, 44143-2131

    Description

    Ingenuity TF PET/CT. Diagnostic imaging system

    Reason

    The system may not default to the same gating trigger with which the data were acquired. This could cause a risk for patients.

    Action

    Philips Medical Systems (Cleveland), Inc. sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated January 21, 2013 to the affected customer. The letter identified the product, problem, and actions to be taken by the customer. Contact your local Philips representative or Philips Healthcare office for further information concerning this issue.

    Distribution

    Distributed only in Ohio.

    Quantity

    1 Unit