Devices

Device Recall Monaco Radiation Treatment Planning System

Model / Serial
Monaco Release 2.0.1 and above
Product Classification
Radiology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA (nationwide) and the countries of Australia, Austria, Belgium, China, Finland, France, Germany, India, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, South Korea, Spain, Switzerland, Taiwan, Thailand and United Kingdom.
Product Description
Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above || Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has been prescribed.
Manufacturer
Computerized Medical Systems Inc
1 Event
- Recall of Device Recall Monaco Radiation Treatment Planning System

Manufacturer

Computerized Medical Systems Inc

Manufacturer Address
Computerized Medical Systems Inc, 13723 Riverport Drive, Suite 100, Maryland Heights MO 63043
Manufacturer Parent Company (2017)
Elekta AB
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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