Z-0841-2013Class II

Monaco RTP System. Radiation treatment planning

Name: Z-0841-2013 Monaco RTP System. Radiation treatment planning
Creator: Elekta, Inc.
Published: 2013-02-11
License: https://open.fda.gov/license/

Elekta Limited / initiated 2013-02-11 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Monaco RTP System. Radiation treatment planning on 2013-02-11. FDA classified it as Class II and gives the reason as "The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0841-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-11
Posted: 2013-02-20
Terminated: 2014-01-21
Recalling firm: Elekta Limited
Product: Monaco RTP System. Radiation treatment planning.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: The beam is displayed at the "gantry" angle, but the dose is calculated at the "rotation_start" angle.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Elekta provided customers with an "Important Safety Notice - Dose Display Not Matching Beam Geometry - Monaco RFC 35748". The notice identified the product, problem, and actions to be taken by the customers. Contact the form at 800-878-4267 for questions relating to this notice.
Quantity in commerce: 13
Distribution: Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
Product codes and lots: Versions 3.20.00 and 3.20.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0841-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0841-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

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)