Z-1879-2016Class II

Monaco RTP System

Name: Z-1879-2016 Monaco RTP System
Creator: Elekta, Inc.
Published: 2016-05-18
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-05-18 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy on 2016-05-18. FDA classified it as Class II and gives the reason as "When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined". 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-1879-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-18
Posted: 2016-06-02
Terminated: 2021-09-15
Recalling firm: Elekta Limited
Product: Monaco RTP System Product Usage: 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: When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
Root cause tag: software
FDA root cause: Software design
Action: Field Safety Notice 382-01-MON-004 was sent to customers on May 18, 2016. The notice informs users of the specific product and version numbers affected by both issues, and any work around that can be used to avoid the issue. The customers were instructed to complete and return the Field Safety Notice Acknowledgement form to their local Elekta as soon as possible.
Quantity in commerce: 1401 units
Distribution: Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe
Product codes and lots: Monaco versions 5.10.00 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1879-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1879-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-06-02

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)