Z-2712-2016Class II

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

Name: Z-2712-2016 Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation...
Creator: Elekta, Inc.
Published: 2016-08-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-08-18 / Terminated

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 2016-08-18. FDA classified it as Class II and gives the reason as "In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2712-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-18
Posted: 2016-09-01
Terminated: 2025-02-28
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: In a specific workflow where contours are edited (enlarged, moved, copied, etc.) and then the contour is deleted on some slices and saved in the same session, it is possible that the deleted contours are still present which would not be the intent of the planner.
FDA root cause: Unknown/Undetermined by firm
Action: Important User Notice 382-03-MON-003 was sent to customers on August 18, 2016. The notice informs users of the specific product and version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The letter also states that the problem will be in a future Monaco release. The customers were instructed to complete and return the Important Field Safety Notice Acknowledgement form to their local Elekta as soon as possible but no longer than 30 days from receipt. Questions can be directed to the local Elekta office.
Quantity in commerce: 3,012 units
Distribution: Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Nambia, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.
Product codes and lots: Software 3.1 and higher.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2712-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2712-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-09-01

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)