Z-0660-2017Class II

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

Name: Z-0660-2017 Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation...
Creator: Elekta, Inc.
Published: 2016-11-03
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-11-03 / Terminated / 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 2016-11-03. FDA classified it as Class II and gives the reason as "Incorrect Dose when using the reset function". 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-0660-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-03
Posted: 2016-11-25
Terminated: 2021-07-16
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 when using the reset function.
Root cause tag: software
FDA root cause: Software design
Action: Important Field Safety Notice 382-01-MON-006 was sent to all affected customers on 11/3/2016. The notice informs users of the specific product and version numbers affected by the issue, and any work around that can be used to avoid the issue. An acknowledgement form was included which is to be returned to Elekta.
Quantity in commerce: 671
Distribution: AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,
Product codes and lots: Software Builds 5.11 and 5.20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0660-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0660-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-07	2016-11-25

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)