FDA recall Z-2406-2026

Elekta, Inc. · Class II · device

Product

MOSAIQ Oncology Information System

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2026-05-21
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2406-2026