CLASS II Device recall · Reported 6 Mar 2019 · FDA Enforcement Report

Monaco Radiation Treatment Planning (RTP) System recalled by Elekta

Elekta is recalling Monaco Radiation Treatment Planning (RTP) System, distributed in Texas, Wisconsin. The recall was initiated on 8 Feb 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware version 5.40

Quantity recalled14 devices

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-0965-2019
FDA event ID: 82072
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 8 Feb 2019
FDA classified: 27 Feb 2019
Reported: 6 Mar 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Feb 2019	Recall initiated by company
27 Feb 2019	Classified by FDA	+19 days
6 Mar 2019	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

If Improve Target Dose was chosen as an optimization model in a previous treatment session, Monaco¿ will automatically use this optimization model again when proceeding with the online plan adaptation of a completion plan when it should not.

Product as listed by the FDA

Monaco Radiation Treatment Planning (RTP) System

Where it was distributed

Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

Texas Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

Software version 5.40

Where was it sold?

Domestic distribution to Wisconsin, Texas. International distribution to Denmark, England, Germany, Netherlands, Sweden.

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 26 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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