Z-2560-2011

Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment...

Name: Z-2560-2011 Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment...
Creator: Computerized Medical Systems Inc
Published: 2008-06-30
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-06-30 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam... on 2008-06-30. The reason FDA records is "Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2560-2011
Status: Terminated
Initiated: 2008-06-30
Posted: 2011-06-14
Terminated: 2013-04-04
Recalling firm: Elekta Limited
Product: Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2. Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Monaco: If the user selects Monte Carlo Photon as the Secondary Algorithm (to be used for final dose calculation through segments), and selects SKIP Forward button at any time during stage 2 optimization, the system may only use the pencil beam algorithm for final computation of dose even though Monte Carlo was selected. Other than specific output to the console window, there will be no other in
Root cause tag: software
FDA root cause: Software design
Action: Computerized Medical Systems, Inc. sent a "MONACO CUSTOMER ADVISORY" letter dated June 2008 to all affected customers. The letter describes the product, problem, and the action to be taken. The customer was instructed to use caution when using the Skip Forward button in stage 2 according to written instructions provided in the letter. This defect exists in Monaco Release 1.0.0 through 1.0.2 and will be resolved as soon as possible. Note: The issue was resolved in Monaco Release 2.0.1 and above. Questions should be directed to the manufacturer's representative telephone number at 408-830-8023.
Quantity in commerce: 47
Distribution: Worldwide Distribution-- USA (nationwide) including the states of IL, MI, MO, OR, SC, TX, VA, and Puerto Rico and the countries of Canada, China, Cyprus, Estonia, France, Germany, Greece, Italy, Japan, Netherlands, Philippines, Poland, Portugal, Slovenia, South Korea, Spain, and United Kingdom.
Product codes and lots: XiO Release 1.0.0 through 1.0.2 All lot or serial numbers

Product code MUJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)