---
title: "X80 RADiant Photoelectric Therapy System — FDA record Z-1404-2022 | Is It on Recall"
description: "There is a potential compatibility issue with the systems and replacement treatment applicators."
url: https://isitonrecall.com/recall/fda-device-z-1404-2022-x80-radiant-photoelectric-therapy-system/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# X80 RADiant Photoelectric Therapy System — FDA record Z-1404-2022

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 27, 2022. 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**: X80 RADiant Photoelectric Therapy System
- **Reason**: There is a potential compatibility issue with the systems and replacement treatment applicators.
- **Classification**: Class II
- **Recalling firm**: Xstrahl Limited
- **Quantity**: 7 devices; 70 treatment applicators
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1404-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1404-2022%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: X80 RADiant Photoelectric Therapy System; Lot Codes: GM0549, GM0567 GM0568, GM0569, GM0570, GM0571 and GM0577; UDI/DI: 5060494200008 |

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

## Distribution

US Distribution FL, CA, KY

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/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)

## Dates in the source

- **Report date**: Jul 27, 2022
- **Recall initiation date**: Apr 27, 2022
- **Center classification date**: Jul 19, 2022

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-1404-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Xstrahl Limited records](https://isitonrecall.com/brand/xstrahl-limited/)