Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Recall
- Recall Number
- Z-1879-2016
- Event Number
- 74164
- Firm
- Elekta, Inc.
- FEI Number
- 1037831
- Product Code
- MUJ
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- May 18, 2016
- Terminated
- September 15, 2021
- Address
- 400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227
Description
Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
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.
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.
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
1401 units