FDA Medical devices recall ·
MOSAIQ Oncology Information System recall
- Recall number
- Z-2406-2026
- Date
- (initiated May 21, 2026)
- Company / brand
- Elekta, Inc.
400 Perimeter Center Ter NE Ste 50, Atlanta, GA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12 programs
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MOSAIQ Oncology Information System
Why was it recalled?
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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.
States: Florida Iowa Kansas Louisiana New Jersey New Mexico New York Texas Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2406-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.