FDAClass II · Medical device · Recalled June 17, 2026
MOSAIQ Oncology Information System recall — Elekta, Inc.
Hazard: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2406-2026
- Brand
- Elekta
- Classification
- Class II
- Units affected
- 12 programs
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
MOSAIQ Oncology Information System
Affected products
Companies & origin
- Recalling firm location
- Atlanta, GA, United States
- Firm address
- 400 Perimeter Center Ter NE Ste 50, N/A, 30346-1227
Identifying details (verbatim from the notice)
- Product codes / lots
- Software Version: MOSAIQ 3.2/UDI: 07340201500071
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 98980
- Recall initiated
- May 21, 2026
- FDA classified
- June 11, 2026
- FDA report date
- June 17, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 1:09 AM UTC.
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