MOSAIQ Oncology Information System
FDA device recall Z-1162-2025 · posted 2025-02-12 · Open, Classified
Recall details
- Recalling firm
- Elekta, Inc.
- Reason for recall
- Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- IYE
- Quantity affected
- 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 Thail
- Date initiated
- 2025-01-15
- Date posted
- 2025-02-12
- Location
- Atlanta, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOSAIQ® OIS (Oncology Information System) (K223229) | Elekta Solutions AB | 2023-02-23 |