CLASS II Device recall · Reported 8 Jun 2016 · 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 18 May 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMonaco versions 5.10.00 and higher

Quantity recalled1401 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-1879-2016
FDA event ID: 74164
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 18 May 2016
FDA classified: 2 Jun 2016
Reported: 8 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

18 May 2016	Recall initiated by company
2 Jun 2016	Classified by FDA	+15 days
8 Jun 2016	Published in enforcement report	+6 days

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

Reason for recall

When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.

Product as listed by the FDA

Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Where it was distributed

Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe

Nationwide Alaska Arizona California Colorado Florida Georgia Illinois Indiana Kentucky Michigan Minnesota Missouri Montana North Carolina New Hampshire New Jersey Nevada New York Oklahoma Oregon

Questions about this recall

Is Monaco RTP System recalled?

Yes. Elekta recalled Monaco RTP System on 18 May 2016. The recall is Class II and its status is Terminated. Recall number Z-1879-2016.

Why was it recalled?

When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.

Which lots are affected?

Monaco versions 5.10.00 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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