FDAClass IIJune 17, 2026

MOSAIQ Oncology Information System recall: Software Issue

MOSAIQ Oncology Information System

Why was MOSAIQ Oncology Information System recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Software Version: MOSAIQ 3.2/UDI: 07340201500071

Product
MOSAIQ Oncology Information System
Recalling firm
Elekta, Inc.
Quantity
12 programs
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.
Recall date
June 17, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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