---
title: "ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Th... — FDA record Z-0447-2024 | Is It on Recall"
description: "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 de"
url: https://isitonrecall.com/recall/fda-device-z-0447-2024-elekta-axesse-ref-xrt-2181-xrt-27891-medical-charged-particle-radiation-therapy-system-accelerator-l/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear — FDA record Z-0447-2024

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 25, 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**: ELEKTA AXESSE, REF XRT 2181, XRT 27891; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Elekta, Inc.
- **Quantity**: 47 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0447-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0447-2024%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 | UDI/DI N/A, Serial Numbers: 152140, 152617, 152691, 152004, 152683, 152994, 153935, 152620, 152809, 152854, 152867, 152885, 152964, 152974, 153192, 153217, 153527, 152499, 153668, 152519, 153118, 153102, 153204, 153166, 152017, 152112, 152325, 152749, 152754, 152755, 152756, 152860, 153006, 151874, 152538, 152839, 152921, 153149, 153267, 152736, 151793, 151802, 151812, 151960, 152600, 152678, 152838 |

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

## Distribution

worldwide

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 13, 2023
- **Recall initiation date**: Oct 25, 2023
- **Center classification date**: Dec 1, 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-0447-2024%22)

## Related records

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