Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Company
- Elekta, Inc.
- Recall Initiated
- November 17, 2016
- Terminated
- December 17, 2021
- Recall Number
- Z-0668-2017
- Quantity
- 2148
- Firm Location
- Atlanta, GA
Reason for Recall
Contours are not handled correctly if the CT dataset contains slices with DICOM Z coordinates of xx.x50mm.
Distribution
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.
Lot / Code Info
Software Builds 5.00 and higher
Root Cause
Software design
Action Taken
Elekta sent an Important Field Safety Notice 382-01-MON-007 was sent to all affected customers on November 17, 2016, to all affected customers. The notice informs users of the specific product version numbers affected by the issue, and any work arounds that can be used to avoid the issue. The notice included a reply form which is to be returned.