- Recalling firm
- Elekta, Inc.
- Reason for recall
- Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
- Affected products (lot / model / serial)
- Software Version: MOSAIQ 3.2/UDI: 07340201500071
- Units affected
- 12 programs
- 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.
- Firm location
- Atlanta, GA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2406-2026
- Recall initiated
- May 21, 2026
- FDA classification date
- June 11, 2026
- FDA report date
- June 17, 2026
- FDA event ID
- 98980
- Last updated on HTM Vibe
- July 23, 2026