FDA-Device2026-06-17Class IIPROCESSING DEFECT
Elekta MOSAIQ Oncology Information System software may fail to load treatment plans during communication errors
What this means
Elekta's MOSAIQ Oncology Information System software (version 3.2) may fail to load an adapted baseline shift plan during cancer treatment delivery if a communication error occurs. This could affect the accuracy of radiation therapy positioning. No injuries have been reported.
- If you operate or manage this system, contact Elekta immediately for guidance on this issue
- Review your institution's communication protocols and error-handling procedures for treatment delivery
- Monitor treatment sessions for any signs of plan-loading errors
The agency's original wording
Hazard
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
12 programs
Manufactured in
400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
Products
MOSAIQ Oncology Information System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2406-2026Want us to check the next one for you?
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