Z-2277-2013Class II

Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning

Name: Z-2277-2013 Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning
Creator: Elekta, Inc.
Published: 2013-05-22
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-05-22 / Terminated / root cause: labeling and UDI

FDA source

Elekta, Inc. began a recall of Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning on 2013-05-22. FDA classified it as Class II and gives the reason as "Patient needs to be positioned as indicated by the treatment plan". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2277-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-22
Posted: 2013-09-25
Terminated: 2013-12-23
Recalling firm: Elekta Limited
Product: Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Patient needs to be positioned as indicated by the treatment plan.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Computerized Medical Systems issued an Important Safety Notice dated May 22, 2013 to all affected customers. This letter idenitfies the problems the products and the actions needed to be takem by the custom.
Quantity in commerce: 72
Distribution: Distributed in Puerto Rico and the states of AK, AZ, CA, CO, CT, FL, IL, IN, MA, MD, MI, MN, MO, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, and WA.
Product codes and lots: All versions of Monaco

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2277-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2277-2013	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)