Recall Z-1162-2025 · IYE Accelerator, Linear, Medical
Elekta, Inc.
MOSAIQ Oncology Information System
| Date | Feb 12, 2025 (initiated Jan 15, 2025) |
| Status | Open, Classified |
| Reason | Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale. |
| Root cause | Software design |
| 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 no |
| Quantity | 64 units |
| Distribution | 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 |
| 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 |