Recall Z-2406-2026 · IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System
| Date | Jun 11, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs. |
| Root cause | Software design |
| 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. |
| Quantity | 12 programs |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223229 | MOSAIQ® OIS (Oncology Information System) Elekta Solutions AB, Feb 23, 2023 |