Elekta, Inc.: Device Recall
Recall #Z-1162-2025 · 01/15/2025
Class II: Risk
Recall Details
- Recall Number
- Z-1162-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Elekta, Inc.
- Status
- Ongoing
- Date Initiated
- 01/15/2025
- Location
- Atlanta, GA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 64 units
Reason for Recall
Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Product Description
MOSAIQ Oncology Information System
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
Other Recalls by Elekta, Inc.
- Class II: Risk 12/14/2025
- Class II: Risk 12/10/2025
- Class II: Risk 09/30/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.