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CLASS II · ModerateFDA

Elekta, Inc. recalls MOSAIQ Oncology Information System

📅 May 21, 2026 · 📍 Nationwide
Recalling company
Elekta, Inc.
Product
MOSAIQ Oncology Information System
Reason
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
May 21, 2026
Reported
Jun 17, 2026
Distribution
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.
Status
Ongoing
Quantity
12 programs
Lot / codes
Software Version: MOSAIQ 3.2/UDI: 07340201500071
Company location
Atlanta, GA
Recall type
Voluntary: Firm initiated
Recall number
Z-2406-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2406-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.