CLASS II ONGOING Device recall · Reported 7 Aug 2019 · FDA Enforcement Report

Monaco RTP System recalled by Elekta

Elekta is recalling Monaco RTP System. The recall was initiated on 3 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11

Quantity recalled1396 units

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-2091-2019
FDA event ID: 83273
Recalling firm: Elekta, Maryland Heights, MO
Classification: Class II
Status: Ongoing
Recall initiated: 3 Jul 2019
FDA classified: 27 Jul 2019
Reported: 7 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Medical Software

Timeline

3 Jul 2019	Recall initiated by company
27 Jul 2019	Classified by FDA	+24 days
7 Aug 2019	Published in enforcement report	+11 days

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

Reason for recall

When creating 3D plans using either MU or Dose weighting modes, if the user changes the number of fractions, rescales the plan and then changes the wedge angle, the Monitor Units are scaled incorrectly.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System

Where it was distributed

worldwide

Questions about this recall

Is Monaco RTP System recalled?

Yes. Elekta recalled Monaco RTP System on 3 Jul 2019. The recall is Class II and its status is Ongoing. Recall number Z-2091-2019.

Why was it recalled?

Which lots are affected?

all Monaco Radiation Treatment Planning units installed with software version 5.10 or 5.11

Where was it sold?

worldwide

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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