Recall Z-0503-2026 · IYE Accelerator, Linear, Medical
ELEKTA SOLUTIONS AB
MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3.4 (01)07340201500026(10)3.1.3.4 3.2.1.0 (01)07340201500071(10)3.2.1.0 3.2.1.1 (01)07340201500071(10)3.2.1.1 3.2.1.2 (01)07340201
| Date | Nov 14, 2025 (initiated Sep 17, 2025) |
| Status | Open, Classified |
| Reason | When appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. |
| Root cause | Software design |
| Action | On 09/17/2025, the firm emailed an "URGENT IMPORTANT FIELD SAFETY NOTIFICATION" to customers informing them when appending a care plan that contains one or more wave medication orders, the occurrence and frequency of the appended orders may not match the intended schedule. Customers are instructed to: When appending cycles for care plans that contain additional medication orders with a wave schedule, review and adjust the appended care plan cycles to reflect the clinical intent. Alternatively, wave orders can be removed from the care plan folder. Additional information can be found in: Custom |
| Quantity | 4 systems that contain the affected software. |
| Distribution | Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223229 | MOSAIQ® OIS (Oncology Information System) Elekta Solutions AB, Feb 23, 2023 |