MOSAIQ Oncology Information System recall (Elekta, Inc.)
Medical deviceClass IIOngoing
Summary: Elekta, Inc. is recalling MOSAIQ Oncology Information System. Reason: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
What is being recalled
MOSAIQ Oncology Information System
Why
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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. (states named: Florida, Iowa, Kansas, Louisiana, New Jersey, New Mexico, New York, Texas, Wisconsin)
How to tell if yours is affected
Software Version: MOSAIQ 3.2/UDI: 07340201500071
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2406-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 21, 2026 |
| Reported | June 17, 2026 |
| Company | Elekta, Inc. |
| Company location | Atlanta, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12 programs |
More recalls from Elekta, Inc. · all medical device recalls · recalls from May 2026