MOSAIQ Oncology System (Elekta) – Image Offset Risk (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

Recommended Action

Per FDA guidance

On January 15, 2025 Elekta issued a recall notification to affected consignees via Email. Elekta asked consignees to take the following actions. 1. Customers included in the scope of the Field Safety Notice, should not calculate shifts from 2D verification images taken at a non-zero patient support angle (couch angle). 2. Please post this notice in a place accessible to all users, e.g. Instructions for Use, until this action is closed. 3. Advise the appropriate personnel, working with this product, on the content of this letter. 4. You are required to either 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.

Distribution

As reported by FDA

AL, FL, IA, PA, UT