# FDA recall Z-2591-2021

> **Elekta, Inc.** · Class II · device recall initiated 2021-09-02.

## Product

MOSAIQ Oncology Information System

## Reason for recall

A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

## Distribution

Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA.  There was no military/government distribution.    Foreign distribution was made to Australia, Canada, and the United Kingdom.

## Key facts

- **Recall number:** Z-2591-2021
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-02
- **Report date:** 2021-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2591-2021

## Citation

> AI Analytics. FDA recall Z-2591-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2591-2021. Source: US FDA. Licensed CC0.

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