MOSAIQ recallZ-0503-2026 · Elekta Solutions AB · initiated Sep 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Elekta Solutions AB or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0503-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 17, 2025
- Posted by the FDA
- Nov 14, 2025
- Recalling firm
- Elekta Solutions AB
- Quantity
- 4 systems that contain the affected software.
- Product code
- IYE
- FDA submissions
- K223229
- Distribution
- Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa.
Product description
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 3.2.2.0 (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 MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- MOSAIQ 3.2Elekta Solutions AB · Accelerator, Linear, Medical4 recalls25 reports
- MOSAIQElekta Solutions AB · Accelerator, Linear, Medical3 recalls5 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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