Summary
The FDA issued a Class II for MOSAIQ Oncology Information System by Elekta, Inc.. Reason: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs..
Details
Source
Device Recall
External ID
Z-2406-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
Product Description
MOSAIQ Oncology Information System
Lot/Code Info: Software Version: MOSAIQ 3.2/UDI: 07340201500071
Quantity Affected: 12 programs
Reason for Recall
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-21
Company
Atlanta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Elekta, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Elekta, Inc. have FDA actions?
Elekta, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2406-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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