Elekta, Inc. recalls Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam r

Recalled December 7, 2016 · FDA recall Z-0668-2017 · Elekta

Hazard

Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm. · FDA Class II

Units

2148

Sold at

Worldwide Distribution - US including AK, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NY, NC, ND, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico and Internationally to Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Tunisia, Turkey, Unite Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.

Description

Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.

Product

Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Manufacturer(s)

Elekta, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →