FDA-Device2012-07-18Class II

Monaco Product Usage: Planning of radiation therapy

Elekta, Inc.
Hazard

Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.

Sold states
US Nationwide Distribution - including the states of: CA, CT, FL, IL, IN, KY, MI, MN, MO, NJ, NY, NC, OH, OK, OR, PA, WA, and WI
Affected count
38
Manufactured in
4775 Peachtree Industrial Blvd, Bldg 300, #300, Norcross, GA, United States
Products
Monaco Product Usage: Planning of radiation therapy

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2007-2012

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