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Recall Observatory FDA recall evidence

Device product

MOSAIQ Oncology Information System

Z-2406-2026

May 21, 2026

Class II

Product summary

Firm
Elekta, Inc.
Event
Event 98980
Status
Ongoing
Classification
Class II
Quantity
12 programs
Official record key
device-enforcement:Z-2406-2026

Official wording

Reason: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

Code information: Software Version: MOSAIQ 3.2/UDI: 07340201500071

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.

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    Software may fail to