Z-0668-2017Class II

Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for...

Name: Z-0668-2017 Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for...
Creator: Elekta, Inc.
Published: 2016-11-17
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-11-17 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy on 2016-11-17. FDA classified it as Class II and gives the reason as "Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm". 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-0668-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-17
Posted: 2016-11-28
Terminated: 2021-12-17
Recalling firm: Elekta Limited
Product: Monaco TRP System The Monaco system is 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: Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Field Safety Notice 382-01-MON-007 was sent to all affected customers on November 17, 2016, to all affected customers. The notice informs users of the specific product version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The notice included a reply form which is to be returned.
Quantity in commerce: 2148
Distribution: Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Unite Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.
Product codes and lots: Software Builds 5.00 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0668-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0668-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-28

Product code MUJ

K132971Class IIMonacoImpac Medical Systems, Inc. / cleared 2013-11-20

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)