Elekta, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0668-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 17, 2016

Date Posted: December 7, 2016

Recall Number: Z-0668-2017

Event ID: 75718

Reason for Recall:

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

Status: Terminated

Product Quantity: 2148

Code Information:

Software Builds 5.00 and higher

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated