Device product
MOSAIQ Oncology Information System
Z-1162-2025
Product summary
- Firm
- Elekta, Inc.
- Event
- Event 96153
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64 units
- Official record key
device-enforcement:Z-1162-2025
Official wording
Reason: Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Code information: Software versions /UDI: 3.1.2.0 (01)07340201500026 3.1.3.0 (01)07340201500026; 3.1.3.1 (01)07340201500026; 3.1.3.2 (01)07340201500026; 3.1.3.3 (01)07340201500026; 3.1.3.4 (01)07340201500026; 3.2.1.0 (01)07340201500071; 3.2.1.1 (01)07340201500071; 3.2.1.2 (01)07340201500071; 3.2.1.3 (01)07340201500071; 3.2.1.4 (01)07340201500071
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
Derived failure modes
-
Device software or design
software may be incorrect