# FDA recall Z-0503-2026

> **ELEKTA SOLUTIONS AB** · Class II · device recall initiated 2025-09-17.

## 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  3.2.2.0 (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.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0503-2026
- **Recalling firm:** ELEKTA SOLUTIONS AB
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-17
- **Report date:** 2025-11-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Stockholm, Sweden

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0503-2026

## Citation

> AI Analytics. FDA recall Z-0503-2026. Retrieved 2026-08-17 from https://api.ai-analytics.org/recall/Z-0503-2026. Source: US FDA. Licensed CC0.

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