FDA Recall Open, Classified

MOSAIQ Oncology Information System

Recall: Z-2406-2026 · Initiated May 21, 2026

Recall

Recall Number
Z-2406-2026
Event Number
98980
Firm
Elekta, Inc.
FEI Number
1037831
Product Code
IYE
Status
Open, Classified
Root Cause
Software design
Initiated
May 21, 2026
Posted
June 11, 2026
Address
400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227

Description

MOSAIQ Oncology Information System

Reason

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

Action

On May 21, 2026, Elekta issued a "Urgent Medical Device Notification to affected to consignees via E-Mail. Elekta asked consignees to take the following actions: 1. Please review this notification and identify if you are running the effected software version listed above. 2. If an Application Communication Time Out error message appears during a BLS plan transfer, please refer to the attached appendix. 3. Please acknowledge receipt of this notification via the Elekta Care Community or complete this form and return it to Elekta immediately upon receipt, but no later than within 30 days. 4. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 5. Advise the appropriate personnel working with this product of the content of this letter. 6. If affected product has been transferred to a different location, please ensure that location and personnel receive a copy of this notification.

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.

Quantity

12 programs