FDA recall, , Moderate risk
MOSAIQ Oncology Information System
MOSAIQ Oncology Information System software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs.
Summary by Recall Canary from the FDA notice
What happened
Elekta, Inc., of Atlanta, Georgia, recalled 12 MOSAIQ Oncology Information System programs because the software may fail to load an adapted baseline shift plan during treatment delivery when a communication error occurs. The FDA added the recall to its Enforcement Report on June 11, 2026, and classified it the same day.
Distribution was worldwide, including U.S. states such as Wisconsin, Florida, Louisiana, New York, New Jersey, Kansas, Iowa, New Mexico and Texas, and countries including Canada, Germany, Japan and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
MOSAIQ Oncology Information System
- UDI-DI
- 07340201500071
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of Wisconsin, Florida, Louisiana, New York, New York, New Jersey, Kansas, Florida, Iowa, New Mexico, Texas 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.
- Company
- Elekta, Inc.Atlanta, Georgia
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98980
- Recall number
- Z-2406-2026
- Quantity recalled
- 12 programs
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated