Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Company
- Elekta, Inc.
- Recall Initiated
- May 18, 2016
- Terminated
- September 15, 2021
- Recall Number
- Z-1879-2016
- Quantity
- 1401 units
- Firm Location
- Atlanta, GA
Reason for Recall
When DICOM exporting a 3D Monaco plan and the "Composite Field Sequencing" (CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
Distribution
Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe
Lot / Code Info
Monaco versions 5.10.00 and higher
Root Cause
Software design
Action Taken
Field Safety Notice 382-01-MON-004 was sent to customers on May 18, 2016. The notice informs users of the specific product and version numbers affected by both issues, and any work around that can be used to avoid the issue. The customers were instructed to complete and return the Field Safety Notice Acknowledgement form to their local Elekta as soon as possible.