Z-2276-2013Class II

Monaco RTP System Radiation treatment planning

Name: Z-2276-2013 Monaco RTP System Radiation treatment planning
Creator: Elekta, Inc.
Published: 2013-07-02
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-07-02 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of Monaco RTP System Radiation treatment planning on 2013-07-02. FDA classified it as Class II and gives the reason as "Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2276-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-02
Posted: 2013-09-25
Terminated: 2014-05-08
Recalling firm: Elekta Limited
Product: Monaco RTP System Radiation treatment planning
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Upgrade installation script is designed to overwrite the same pouch files in the Treatment Couch Library with the original default values.
Root cause tag: design
FDA root cause: Device Design
Action: Monaco 3.3 upgrades have been temporarily halted and Important Safety Notice (LINMON0007) has been issued to effected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure that couch files are checked for releases 3.20.00 and 3.30.00 to verify that the correct relative electron density values are being used in the dose calculation. If customers have edited the sample couch files, and previously upgraded to Monaco 3.20.00 or 3.30.00, their couch files have already been overwritten. Open the couch files, make the necessary updates to the couch parameters, and use the "Save As Treatment Couch" option to save the modified sample couch files to a new, unique name. Please note that the couch files can also be edited in Focal and then the patients opened in Monaco. Comparable Focal releases would be Focal4.64.00(Monaco 3.10.00), Focal4.70.00(Monaco 3.20.00) and Focal4.80.00 (Monaco 3.30.00). For questions regarding this recall call 404-993-5886.
Quantity in commerce: 45
Distribution: Nationwide Distribution including AK, CA, CO, CT, FL, IL, IN, MI, MN, MO, NC, NJ, NY, OH, OK, OR, PA, SC, TN, TX, WA and Puerto Rico.
Product codes and lots: Versions 3.10.00 and later

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2276-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2276-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-02	2013-09-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)