Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MOSAIQ Oncology Information System Software Builds 3.1.3 Recalled by ELEKTA SOLUTIONS AB Due to When appending a care plan that contains one...

Date: September 17, 2025
Company: ELEKTA SOLUTIONS AB
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ELEKTA SOLUTIONS AB directly.

Affected Products

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.

Quantity: 4 systems that contain the affected software.

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ELEKTA SOLUTIONS AB

ELEKTA SOLUTIONS AB has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report