Device product
MOSAIQ Oncology Information System
Z-2406-2026
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 98980
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 programs
- Official record key
device-enforcement:Z-2406-2026
Official wording
Reason: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Code information: Software Version: MOSAIQ 3.2/UDI: 07340201500071
Distribution pattern: Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
Derived failure modes
-
Device software or design
Software may fail to