# FDA recall Z-0719-2023

> **Elekta, Inc.** · Class II · device recall initiated 2022-12-05.

## Product

Oncentra Brachy radiation therapy planning system software.

## Reason for recall

A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling

## Distribution

Distribution US nationwide, including Puerto Rico.  There was no military/government distribution.

## Key facts

- **Recall number:** Z-0719-2023
- **Recalling firm:** Elekta, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-05
- **Report date:** 2022-12-21

- **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-0719-2023

## Citation

> AI Analytics. FDA recall Z-0719-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0719-2023. Source: US FDA. Licensed CC0.

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