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

Hazard

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

Details from the source

Reason for recall: Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation. Distribution: 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, Greec Quantity: 2,020 units Lot/code info: 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

UPC codes

00858164002169

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.