MOSAIQ Oncology Information System
FDA Recall Z-2406-2026 · Posted 2026-06-11
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Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2026-05-21
Product Quantity12 programs
Reason for Recall
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Firm 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.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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