Recall
FDAHealthMay 21, 2026

Elekta, Inc. — MOSAIQ Oncology Information System

⚠️ Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
May 21, 2026

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.

What's affected?

Product
MOSAIQ Oncology Information System
Lot code
Software Version: MOSAIQ 3.2/UDI: 07340201500071

Additional details

Software Version: MOSAIQ 3.2/UDI: 07340201500071

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 12 programs.

View original FDA notice →

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