Elekta, Inc.: Accelerator, Linear, Medical
Recall Summary Elekta's MOSAIQ Oncology Information System software may fail to load adapted baseline shift plans during cancer treatment delivery when a communication error occurs. This is a Class II recall affecting the company's linear accelerator systems used in cancer treatment facilities. The affected systems have been distributed worldwide, including across the United States and multiple countries.
- Recalling firm
- Elekta, Inc.
- Product
- MOSAIQ Oncology Information System
- Reason
- Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/0db6345c-9316-421a-8dfb-835cfd5f4d89