Z-0076-2017Class II

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

Name: Z-0076-2017 Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for...
Creator: Elekta, Inc.
Published: 2016-09-29
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-09-29 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of Monaco RTP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates... on 2016-09-29. FDA classified it as Class II and gives the reason as "When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0076-2017
Classification: Class II
Status: Terminated
Initiated: 2016-09-29
Posted: 2016-10-13
Terminated: 2021-07-16
Recalling firm: Elekta Limited
Product: Monaco RTP 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 treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
Root cause tag: design
FDA root cause: Device Design
Action: Elekta sent an Important Field Safety Notice 382-01-MON-005 was sent to all affected customers on 9/29/2016. 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 notice included an acknowledgment form which is to be returned. For questions regarding this recall call 314-993-0003 or 800-878-4287.
Quantity in commerce: 365
Distribution: Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI. Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.
Product codes and lots: Software Builds 5.10 and 5.20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0076-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0076-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

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)