Z-1237-2015Class II

Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for...

Name: Z-1237-2015 Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for...
Creator: Elekta, Inc.
Published: 2014-12-19
License: https://open.fda.gov/license/

Elekta Limited / initiated 2014-12-19 / Terminated

FDA source

Elekta, Inc. began a recall of Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam... on 2014-12-19. FDA classified it as Class II and gives the reason as "Incorrect CT to ED when using the Monaco Image Statistics Tool". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1237-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-19
Posted: 2015-03-02
Terminated: 2017-11-17
Recalling firm: Elekta Limited
Product: Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Incorrect CT to ED when using the Monaco Image Statistics Tool.
FDA root cause: Other
Action: Elekta sent an Important User Notice on December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This notice provided a workaround until new software releases. The notice included a acknowledgement form to be returned. For further questions please call (770) 300-9725
Quantity in commerce: 1354
Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Algeria, Ecuador, Spain, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Kazakhstan, Sri Lanka, Lithuania, Libya, Morocco, Myanmar, Malta, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, Venezuela and South Africa.
Product codes and lots: Monaco Release 3.30 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1237-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1237-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-02

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)