Recall archive / FDA device enforcement
MOSAIQ Oncology Information System — FDA record Z-1162-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 15, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- MOSAIQ Oncology Information System
- Reason
- Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
- Classification
- Class II
- Recalling firm
- Elekta, Inc.
- Quantity
- 64 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1162-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 19, 2025
- Recall initiation date
- Jan 15, 2025
- Center classification date
- Feb 11, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.