Z-1233-2023Class II

Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation...

Name: Z-1233-2023 Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation...
Creator: Elekta Inc
Published: 2023-02-28
License: https://open.fda.gov/license/

Elekta Limited / initiated 2023-02-28 / Open, Classified / root cause: software

FDA source

Elekta Inc began a recall of Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy on 2023-02-28. FDA classified it as Class II and gives the reason as "Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1233-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-28
Posted: 2023-03-08
Recalling firm: Elekta Limited
Product: Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Root cause tag: software
FDA root cause: Software design
Action: Elekta notified consignees of the issue on 02/28/2023 via email. Consignees were instructed to contact Elekta Care Support if assistance is needed to identify affected patients, post the recall information in a place accessible to all users until the action is complete, and complete and return the Important Field Safety Notice Acknowledgement form. Additionally, the issue is corrected in Monaco releases 5.40 and above. If you are running a 5.11.xx version, please contact Elekta Care Support to upgrade to a newer software version.
Quantity in commerce: 2,020 units
Distribution: Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territory, Occupied, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Zimbabwe.
Product codes and lots: Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1233-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1233-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-15	2023-03-07

Product code MUJ

K151233Class IIMonacoImpac Medical Systems, Inc. / cleared 2015-07-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)