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U.S. Department of Health and Human Services

Class 2 Device Recall MOSAIQ Oncology Information System

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 Class 2 Device Recall MOSAIQ Oncology Information Systemsee related information
Date Initiated by FirmMay 21, 2026
Date PostedJune 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2406-2026
Recall Event ID 98980
510(K)NumberK223229 
Product Classification Accelerator, linear, medical - Product Code IYE
ProductMOSAIQ Oncology Information System
Code Information Software Version: MOSAIQ 3.2/UDI: 07340201500071
FEI Number 1037831
Recalling Firm/
Manufacturer		 Elekta, Inc.
400 Perimeter Center Ter NE Ste 50
Atlanta GA 30346-1227
For Additional Information ContactElekta Care Support
001-855-6935358
Manufacturer Reason
for Recall		Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
FDA Determined
Cause 2		Software design
ActionOn 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.
Quantity in Commerce12 programs
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IYE
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