MOSAIQ Oncology System (Elekta) – Care Plan Order Error (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.
Brand
ELEKTA SOLUTIONS AB
Lot Codes / Batch Numbers
Software Versions: 3.1.3, 3.2.1
Products Sold
Software Versions: 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 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)07340201500071(10)3.2.1.2 3.2.1.3 (01)07340201500071(10)3.2.1.3 3.2.1.4 (01)07340201500071(10)3.2.1.4 3.2.2.0 (01)07340201500071(10)3.2.2.0 3.2.2.1 (01)07340201500071(10)3.2.2.1 3.2.3.0 (01)07340201500071(10)3.2.3.0
ELEKTA SOLUTIONS AB is recalling MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version a due to 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 int. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026