MOSAIQ Oncology Information System
FDA Recall Z-1162-2025 · Posted 2025-02-12
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Recalling FirmElekta, Inc.
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2025-01-15
Product Quantity64 units
Reason for Recall
Image offsets calculated by oncology Information System
software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Firm Action
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.
Root Cause
Software design
Distribution Pattern
US: PA, AL, FL, IA UT OUS: Austria Belgium Bolivia Bosnia and Herzegowina Brazil Canada France Germany Hong Kong Italy Japan Korea, Republic of Malta Netherlands Panama South Africa Spain Taiwan Thailand Turkey Venezuela
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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