CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Monaco RTP System recalled by Elekta

Elekta is recalling Monaco RTP System, distributed nationwide in the US. The recall was initiated on 21 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Versions 5.00 and higher

Quantity recalled279

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1009-2017
FDA event ID: 76028
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 21 Dec 2016
FDA classified: 11 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Dec 2016	Recall initiated by company
11 Jan 2017	Classified by FDA	+21 days
18 Jan 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

Product as listed by the FDA

Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Where it was distributed

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

Nationwide California Indiana Kentucky Massachusetts North Carolina New Jersey New York Pennsylvania Texas Wisconsin

Questions about this recall

Is Monaco RTP System recalled?

Yes. Elekta recalled Monaco RTP System on 21 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-1009-2017.

Why was it recalled?

Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations.

Which lots are affected?

Software Versions 5.00 and higher

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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