Z-0112-2016Class II

Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for...

Name: Z-0112-2016 Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for...
Creator: Elekta, Inc.
Published: 2015-09-15
License: https://open.fda.gov/license/

Elekta Limited / initiated 2015-09-15 / Terminated / root cause: design

FDA source

Elekta, Inc. began a recall of Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy on 2015-09-15. FDA classified it as Class II and gives the reason as "Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities". 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-0112-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-15
Posted: 2015-10-07
Terminated: 2017-04-04
Recalling firm: Elekta Limited
Product: Monaco Radiation Treatment Planning 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: Dose and MU are incorrect when CT images are viewed from the head, and, when using multiple prescriptions with forced densities.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued an URGENT IMPORTANT FIELD SAFETY NOTICE on 09/15/2015. The letter identified the affected device, as well as the reason for the recall, and clinical impact. Customers were informed that both issues would be resolved in Monaco Patch Release 5.10.01. The attached acknowledgement form should be completed, signed, and returned to a local Elekta Office or representative within 30 days. Questions regarding the notice should be directed to a local Elekta office.
Quantity in commerce: 154 units
Distribution: Worldwide Distribution -- US, including the states of CA, IN, MI, MO, TX and WI; and, the countries of Australia, Canada, Germany, Greece, India, Netherlands, New Zealand, Turkey, and the UK.
Product codes and lots: Software Version 5.10.00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0112-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0112-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-07

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)