Z-2406-2026 Class II Ongoing
FDA device recall Z-2406-2026 was initiated by Elekta, Inc. on May 21, 2026 and is designated Class II. Reason for recall: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. The recall status is ongoing. Affected quantity: 12 programs.
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- May 21, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 programs
Product Description
MOSAIQ Oncology Information System
Reason for Recall
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Distribution Pattern
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.
Code Information
Software Version: MOSAIQ 3.2/UDI: 07340201500071