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Elekta Inc Recall 91773

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

Elekta Inc Recall 91773 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1233-2023
Event ID91773
Event DescriptionMonaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Product TypeDevices
DistributionNationwide 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.
Quantity2,020 units
Recall ReasonRe-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Device Classification20230315
Device Code InfoSoftware 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
Center Classification Date20230307
Recall Initiation Date20230228
Recalling FirmElekta Inc
Initial Notification E-Mail
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