BEUDAMED
    FDA Recall Terminated

    Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.

    Recall: Z-2561-2011 · Initiated January 13, 2011

    Recall

    Recall Number
    Z-2561-2011
    Event Number
    57760
    Firm
    Computerized Medical Systems Inc
    FEI Number
    1937649
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 13, 2011
    Posted
    June 14, 2011
    Terminated
    April 3, 2014
    Address
    13723 Riverport Drive, Suite 100, Maryland Heights, MO, 63043

    Description

    Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above. The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.

    Reason

    Monaco: For VMAT plans, the measured dose of radiation delivered is lower than the software calculated dose by about 5% in Monaco Release 2.03.00 and 2.04.00.

    Action

    Computerized Medical Systems, Inc. sent a "USER NOTICE" on January 13, 2011, to all affected users. This notice identified the product, the problem, and the action needed to be taken by the customer. A return postcard is included for the customer to confirm receipt of the user notification. The firm intends for correction in the dose calulation engine to appear in the Monaco Release 3.00 in March 2011. Any further questions please call (403) 830-8023.

    Distribution

    Worldwide Distribution-- USA (nationwide) and countries of Austria, Australia, Belarus, Canada, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, Poland, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand and UK.

    Quantity

    94