FDA Device recall Z-1162-2025
MOSAIQ Oncology Information System
- FDA Device
- Class II
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class II recall of MOSAIQ Oncology Information System by Elekta, citing image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1162-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-15 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Elekta |
| Distribution | AL, FL, IA, PA, UT |
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.
Identifiers
| code_info | 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)…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1162-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.