Elekta, Inc.: Mosaiq Oncology Information System

MOSAIQ Oncology Information System Recall Summary Elekta, Inc. is recalling the MOSAIQ Oncology Information System software because it may fail to load a patient's adapted baseline shift plan during cancer treatment when a communication error occurs. This is a Class II recall affecting cancer treatment centers worldwide, including locations across the United States and multiple countries. The software malfunction could prevent the system from applying necessary treatment plan adjustments during radiation therapy delivery.

Recalling firm
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
Category
medical device recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-05-21
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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,...

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/4437b0a5-6901-4cb0-ae4e-9463b30e62f3