Elekta MOSAIQ Oncology Information System software may fail to load treatment plans during communication errors
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.
From the FDA notice · Read the official notice ↗ · All Elekta recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- MOSAIQ Oncology Information System
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 12 programs
- Illnesses reported
- None reported
- Manufactured in
- 400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, United States
- Classification
- Class II
- Recall number
- Z-2406-2026
In the FDA's words
- Description
- MOSAIQ Oncology Information System Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. 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. Affected quantity: 12 programs
- Hazard
- Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.