Z-1009-2017Class II

Monaco RTP System

Name: Z-1009-2017 Monaco RTP System
Creator: Elekta, Inc.
Published: 2016-12-21
License: https://open.fda.gov/license/

Elekta Limited / initiated 2016-12-21 / Terminated / root cause: manufacturing process

FDA source

Elekta, Inc. began a recall of Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy on 2016-12-21. FDA classified it as Class II and gives the reason as "Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations". 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-1009-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-21
Posted: 2017-01-11
Terminated: 2021-07-16
Recalling firm: Elekta Limited
Product: Monaco RTP System Product Usage: 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: Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Elekta sent an Urgent Important Field Safety Notification letter dated December 2016 to customers. 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 a reply form to be returned to Elekta.
Quantity in commerce: 279
Distribution: Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey
Product codes and lots: Software Versions 5.00 and higher

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1009-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1009-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-18	2017-01-11

Product code MUJ

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)