---
title: "SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System — FDA record Z-0517-2024 | Is It on Recall"
description: "Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements."
url: https://isitonrecall.com/recall/fda-device-z-0517-2024-sagiplan-2-2-ce0344-rx-only-brachyterapy-treatment-planning-system/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System — FDA record Z-0517-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 17, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
- **Reason**: Due to software malfunction, numerical values may be rounded resulting in inaccurate measurements.
- **Classification**: Class II
- **Recalling firm**: Bebig Isotopentechnik Gmbh
- **Quantity**: 2 software licenses in US, 255 software licenses in OUS
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0517-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0517-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | SagiPlan, article # 1374-0600, version 2.2 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: MD OUS: Germany

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Maryland](https://isitonrecall.com/state/maryland/)

## Dates in the source

- **Report date**: Dec 20, 2023
- **Recall initiation date**: Oct 17, 2023
- **Center classification date**: Dec 8, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0517-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Bebig Isotopentechnik Gmbh records](https://isitonrecall.com/brand/bebig-isotopentechnik-gmbh/)
