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
FDA device recall Z-0503-2026 · posted 2025-11-14 · Open, Classified
Recall details
- Recalling firm
- ELEKTA SOLUTIONS AB
- Reason for recall
- 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.
- Action taken
- 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: Customers with v3.1.3 - section 3.4.1 - page 35-36 in doc E062133 / 01 MOSAIQ 3.1.3.0 Instructions for Use Customers with v3.2.1 - section 3.4.1 - page 35-36 in doc E065117 / 03 MOSAIQ 3.2.1.0 Instructions for Use Customers with v3.2.2 - section 3.4.1 - page 35-36 in doc E067652 / 04 MOSAIQ 3.2.2.0 Instructions for Use Customers with v3.2.3.0 - section 3.4.1 - page 35-36 in doc E071967 / 01 MOSAIQ 3.2.3.0 Instructions for Use For questions - contact Quality Assurance at +46 70-962-0862 or email mats.premfors@elekta.com
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- IYE
- Quantity affected
- 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.
- Date initiated
- 2025-09-17
- Date posted
- 2025-11-14
- Location
- Stockholm, Sweden
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOSAIQ® OIS (Oncology Information System) (K223229) | Elekta Solutions AB | 2023-02-23 |