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Open, Classified

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.

FDA Recall Z-0503-2026 · Posted 2025-11-14

Recalling FirmELEKTA SOLUTIONS AB
Recall StatusOpen, Classified
Product CodeIYE
Date Initiated2025-09-17
Product Quantity4 systems that contain the affected software.

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.

Firm 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: 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]

Root Cause

Software design

Distribution Pattern

Worldwide - U.S. Nationwide distribution in the state of NM and the countries of Canada, Malta, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB · 2023-02-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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