---
title: "Portable X-ray system — FDA record Z-2117-2025 | Is It on Recall"
description: "Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm."
url: https://isitonrecall.com/recall/fda-device-z-2117-2025-portable-x-ray-system/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Portable X-ray system — FDA record Z-2117-2025

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 Jun 19, 2025. 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**: Portable X-ray system
- **Reason**: Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
- **Classification**: Class II
- **Recalling firm**: DIGIMED CO., LTD
- **Quantity**: 530
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2117-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2117-2025%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/Model Name: 08800021800014/DIOX-602 |

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

## Distribution

US

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

## Dates in the source

- **Report date**: Jul 30, 2025
- **Recall initiation date**: Jun 19, 2025
- **Center classification date**: Jul 18, 2025

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-2117-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [DIGIMED CO., LTD records](https://isitonrecall.com/brand/digimed-co-ltd/)