CLASS II ONGOING Device recall · Reported 15 Mar 2023 · 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 28 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03

Quantity recalled2,020 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-1233-2023
FDA event ID: 91773
Recalling firm: Elekta, Saint Charles, MO
Classification: Class II
Status: Ongoing
Recall initiated: 28 Feb 2023
FDA classified: 7 Mar 2023
Reported: 15 Mar 2023
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

28 Feb 2023	Recall initiated by company
7 Mar 2023	Classified by FDA	+7 days
15 Mar 2023	Published in enforcement report	+8 days

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

Reason for recall

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

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

Nationwide distribution in the US. International distribution to Albania, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegowina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cuba, Curacao, Cyprus, Czech Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of, Lao People's Democratic Republic, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Malta, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestinian Territory, Occupied, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Rwanda, Saudi Arabia, Senegal, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Suriname, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam, Zimbabwe.

Nationwide Georgia

Questions about this recall

Is Monaco RTP System recalled?

Yes. Elekta recalled Monaco RTP System on 28 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1233-2023.

Why was it recalled?

Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.

Which lots are affected?

Software Build: 5.11.00, 5.11.01, 5.11.02, 5.11.03; UDI Numbers: (01)00858164002169(10)5.11.00, (01)00858164002169(10)5.11.01, (01)00858164002169(10)5.11.02, (01)00858164002169(10)5.11.03

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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