CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report

Monaco RTP System recalled by Elekta

Elekta is recalling Monaco RTP System, distributed in 27 states. The recall was initiated on 10 Jan 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Builds - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00

Quantity recalled1999

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-1044-2017
FDA event ID: 76198
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 10 Jan 2017
FDA classified: 18 Jan 2017
Reported: 25 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jan 2017	Recall initiated by company
18 Jan 2017	Classified by FDA	+8 days
25 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 dose after editing beam number an wedge angle.

Product as listed by the FDA

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

Where it was distributed

AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Napal, Namibia, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Peru, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Zimbabwe

Arkansas Arizona California Colorado Georgia Illinois Indiana Louisiana Massachusetts Michigan Minnesota Missouri North Carolina New Hampshire New Jersey Nevada New York Ohio Oregon Pennsylvania

Questions about this recall

Is Monaco RTP System recalled?

Yes. Elekta recalled Monaco RTP System on 10 Jan 2017. The recall is Class II and its status is Terminated. Recall number Z-1044-2017.

Why was it recalled?

Incorrect dose after editing beam number an wedge angle.

Which lots are affected?

Software Builds - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00

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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