Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reported: March 15, 2023 Initiated: February 28, 2023 #Z-1233-2023
Product Description
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Reason for Recall
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Details
- Recalling Firm
- Elekta Inc
- Units Affected
- 2,020 units
- 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, 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.
- Location
- Saint Charles, MO
Frequently Asked Questions
What product was recalled? ▼
Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.. Recalled by Elekta Inc. Units affected: 2,020 units.
Why was this product recalled? ▼
Re-optimization, after adding contours without forced density outside the external structure, may result in inaccurate dose presentation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 15, 2023. Severity: Moderate. Recall number: Z-1233-2023.
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