Recalling firm
Elekta, Inc.
Product type
Device
Status
Ongoing
Report date
2026-06-17
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 state
GA
Product quantity
12 programs
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Product description
MOSAIQ Oncology Information System
Code / lot info
Software Version: MOSAIQ 3.2/UDI: 07340201500071
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.