ELEKTA SOLUTIONS AB: Device Recall

Recall #Z-0503-2026 · 09/17/2025

Class II: Risk

Recall Details

Recall Number
Z-0503-2026
Classification
Class II
Product Type
Device
Recalling Firm
ELEKTA SOLUTIONS AB
Status
Ongoing
Date Initiated
09/17/2025
Location
Stockholm, Sweden
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 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.

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.

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.