Z-1365-2012

Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy

Name: Z-1365-2012 Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy
Creator: Computerized Medical Systems Inc
Published: 2012-03-05
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-03-05 / Terminated / root cause: software

FDA source

Computerized Medical Systems Inc began a recall of Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy on 2012-03-05. The reason FDA records is "An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose". 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-1365-2012
Status: Terminated
Initiated: 2012-03-05
Posted: 2012-04-03
Terminated: 2014-04-01
Recalling firm: Elekta Limited
Product: Monaco Radiation Treatment Planning System, Version 3.10.00. Planning of radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: An unnecessary dose refresh can occur in certain situations which causes inconsistencies in the Beam Doses and the Total Dose.
Root cause tag: software
FDA root cause: Software design
Action: An "IMPORTANT SAFETY NOTICE" was issued between 3/5-9/12 via e-mail, FAX, or traditional mail. The Notice described the correct functioning of the system, the problem, when and why the issue occurs, the clinical impact, and the workaround. Patch 3.10.01 is now available. Customers can download their patch at the link provided in the Notice. The Notice also provided a list of offices where customers can contact if they have questions or further support is needed.
Quantity in commerce: 44
Distribution: Worldwide Distribution -- USA, including the states of OH, IN, WI, CA, FL, IL, LA, NJ, MA, NC, and MO and the countries of Canada, Australia, Belgium, China, France, Germany, Japan, The Netherlands, New Zealand, Portugal, Switzerland, Taiwan, and the United Kingdom.
Product codes and lots: Version 3.10.00

Product code MUJ

K110730Class IIMonaco Rtp SystemComputerized Medical Systems, Inc. / cleared 2011-06-24

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)