BEUDAMED
    FDA Recall Terminated

    Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.

    Recall: Z-0836-03 · Initiated April 2, 2003

    Recall

    Recall Number
    Z-0836-03
    Event Number
    26080
    Firm
    Philips Medical Systems (Cleveland) Inc
    FEI Number
    1525965
    Product Code
    JAK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 2, 2003
    Posted
    May 15, 2003
    Terminated
    December 1, 2003
    Address
    595 Miner Rd, Highland Heights, OH, 44143

    Description

    Philips MX8000 Dual v. EXP CT Scanner, utilizing V2.0 software.

    Reason

    Patient images may be incorrectly stored in the archive directory of a different patient.

    Action

    The firm mailed a ''Product Safety Notification'', dated 4/2/2003, to all affected user sites.

    Distribution

    The units were installed in medical facilities located nationwide, and in the following foreign countries: China, Belgium, France, Austria, Germany, Italy, Netherlands, Australia, Israel, Spain, Denmark, Singapore, Switzerland, Russia, South Korea, Canada, United Kingdom, South Africa, Sweden, Japan, Brazil.

    Quantity

    50 installed units (24 domestic)