# FDA recall Z-0446-2024

> **Elekta, Inc.** · Class II · device recall initiated 2023-10-25.

## Product

ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

## Reason for recall

Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms.  When the detector arm is fully deployed there is no risk of uncontrolled extension.

## Distribution

worldwide

## Key facts

- **Recall number:** Z-0446-2024
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-25
- **Report date:** 2023-12-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Atlanta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2024

## Citation

> AI Analytics. FDA recall Z-0446-2024. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0446-2024. Source: US FDA. Licensed CC0.

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