Z-1044-2017Class II

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

Name: Z-1044-2017 Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation...
Creator: Elekta, Inc.
Published: 2017-01-10
License: https://open.fda.gov/license/

Elekta Limited / initiated 2017-01-10 / 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 2017-01-10. FDA classified it as Class II and gives the reason as "Incorrect dose after editing beam number an wedge angle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1044-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-10
Posted: 2017-01-18
Terminated: 2020-08-18
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: Incorrect dose after editing beam number an wedge angle.
FDA root cause: Other
Action: Elekta sent Important Field Safety Notice 382-01-MON-009 to all affected customers on 1/10/2017. The notice informs users of the specific product and version numbers by the issue, and any work arounds that can be used to avoid the issue. The notice informs customers that Elekta Regional Support Staff will contact them directly. The notice also included an acknowledgment form to be returned.
Quantity in commerce: 1999
Distribution: AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Napal, Namibia, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Peru, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Zimbabwe
Product codes and lots: Software Builds - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1044-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1044-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-18

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)