MOSAIQ Oncology Information System
Recall
- Recall Number
- Z-1162-2025
- Event Number
- 96153
- Firm
- Elekta, Inc.
- FEI Number
- 1037831
- Product Code
- IYE
- Status
- Open, Classified
- Root Cause
- Software design
- Initiated
- January 15, 2025
- Posted
- February 12, 2025
- Address
- 400 Perimeter Center Ter NE, Ste 50, Atlanta, GA, 30346-1227
Description
MOSAIQ Oncology Information System
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
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.
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64 units