Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed.
FDA Recall Z-2598-2011 · Posted 2011-06-20
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Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-01-13
Date Terminated2014-04-02
Product Quantity137
Reason for Recall
Monaco: When the isocenter location is edited in the IMRT Activity screen, the shift coordinates are not updated in the IMRT Plan report.
Firm Action
Computerized Medical Systems Inc drafted a User Notice which explains the reason for correction, the clinical impact, and the workaround method. The User Notice was sent January 13, 2011. A return postcard is included for the customer to confirm receipt of the User Notice. The firm intends for this issue to be corrected in Monaco Release 3.00 in March 2011.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (Nationwide distribution to AK, AZ, CA, CO, FL, IL, IN, MA, MI, MN, MO, NC, NM, NY, OH, OR, PA, SC, TX, VA, WA, and WI and the countries of Algeria, Australia, Austria, Belarus, Belgium, Brazil, Canada, Chile, China, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Phillipines, Poland, Portugal, Singapore, Slovenia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, and the United Kindom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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