FDA Enforcement
Class II
Ongoing
MOSAIQ Oncology Information System
Recall: Z-2406-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2406-2026
- Event ID
- 98980
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Elekta, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 17, 2026
- Initiation Date
- May 21, 2026
- Classification Date
- June 11, 2026
- Address
- 400 Perimeter Center Ter NE Ste 50, N/A, Atlanta, GA, 30346-1227, United States
Description
MOSAIQ Oncology Information System
Reason
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Code Info
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.
Quantity
12 programs