---
title: "RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radi... — FDA record Z-1933-2024 | Is It on Recall"
description: "A potential dose error exists for patients treated with an out of session SCINTIX partial fraction."
url: https://isitonrecall.com/recall/fda-device-z-1933-2024-reflexion-x1-radiotherapy-system-model-rxm1000-software-version-2-1-19-3-radiation-therapy-system-is/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that co... — FDA record Z-1933-2024

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 Apr 16, 2024. 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**: RefleXion X1 Radiotherapy System Model RXM1000 Software version 2.1.19-3 Radiation therapy system is a device that combines the functionality of an emission computed tomography detection system and a linear accelerator.
- **Reason**: A potential dose error exists for patients treated with an out of session SCINTIX partial fraction.
- **Classification**: Class II
- **Recalling firm**: Reflexion Medical, Inc.
- **Quantity**: 7 systems
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1933-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1933-2024%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 | Model Number: RXM1000 UDI Codes that includes system serial numbers: (01)00860003983812(11)230504(21)X11001 (01)00860003983812(11)230518(21)X11002 (01)00860003983812(11)230505(21)X11003 (01)00860003983812(11)230530(21)X11004 (01)00860003983812(11)230811(21)X11006 (01)00860003983812(11)230410(21)X11007 (01)00860003983812(11)230803(21)X11008 |

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

## Distribution

U.S.: CA, CT, NJ, OR, PA and TX No O.U.S.

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

- [California](https://isitonrecall.com/state/california/)
- [Connecticut](https://isitonrecall.com/state/connecticut/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jun 5, 2024
- **Recall initiation date**: Apr 16, 2024
- **Center classification date**: May 30, 2024

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-1933-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Reflexion Medical, Inc. records](https://isitonrecall.com/brand/reflexion-medical-inc/)