Elekta, Inc.: MOSAIQ Oncology Information System
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System
- Reason / hazard
- Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-05-21
- Code info
- Software Version: MOSAIQ 3.2/UDI: 07340201500071
- Product quantity
- 12 programs
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Atlanta
- State
- GA
- Country
- United States
- Event id
- 98980
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