Z-2007-2012Class II

Monaco

Name: Z-2007-2012 Monaco
Creator: Elekta, Inc.
Published: 2012-06-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2012-06-21 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Monaco Product Usage: Planning of radiation therapy on 2012-06-21. FDA classified it as Class II and gives the reason as "Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports". 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-2007-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-21
Posted: 2012-07-12
Terminated: 2014-04-01
Recalling firm: Elekta Limited
Product: Monaco Product Usage: Planning of radiation therapy
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
Root cause tag: software
FDA root cause: Software design
Action: Elekta sent an Important Safety Notice to affected customers. The notice identified the affected product, problem, clinical impact and actions to be taken. The notice inform customers of how the issue will be resolved and instructions to follow when it is available.
Quantity in commerce: 38
Distribution: US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
Product codes and lots: Version 3.10.00 - 3.20.00, inclusive

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2007-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2007-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-18	2012-07-12

Product code MUJ

K110730Class IIMonaco Rtp SystemComputerized Medical Systems, Inc. / cleared 2011-06-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)