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Terminated

Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.

FDA Recall Z-2569-2011 · Posted 2011-06-15

Recalling FirmComputerized Medical Systems Inc
Recall StatusTerminated
Product CodeMUJ
Date Initiated2010-10-27
Date Terminated2014-04-02
Product Quantity11

Reason for Recall

Monaco: In XiO IMRT (Dynamic MLC Delivery) software, the radiation beam angle is set to zero. If different beam angles are selected via Monaco software, the beam angles will remain at zero.

Firm Action

Computerized Medical Systems, Inc. sent a User Notice to the affected consignees on October 27, 2010, explaining the reason for correction, the clinical impact, and the workaround method. (VERIFY USE NOTICE DATE) A return postcard was 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 including CA, IL, MN, NM, OH, NY, TX, and WA and the Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K091179MONACO RTP SYSTEM, VMAT OPTIONComputerized Medical Systems, Inc. · 2009-07-16K071938MONACO RTP SYSTEMComputerized Medical Systems, Inc. · 2007-10-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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