---
title: "Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x... — FDA record Z-0781-2024 | Is It on Recall"
description: "Some parts have fallen off the equipment resulting in a safety risk to patients and/or users."
url: https://isitonrecall.com/recall/fda-device-z-0781-2024-sedecal-x-optima-urs-digital-mobile-diagnostic-x-ray-system-a-a-stationary-x-ray-unit-with-a-univers/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. I... — FDA record Z-0781-2024

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 Dec 13, 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**: Sedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit with a universal swivel arm. It allows one to take exposures of patients in standing, sitting, or laying position.
- **Reason**: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
- **Classification**: Class II
- **Recalling firm**: SEDECAL SA
- **Quantity**: 845 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0781-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0781-2024%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 | All serial numbers, UDI-DI 08436046002500. |

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

## Distribution

Distribution was made to AL, FL, and NC. There was no military/government distribution.

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

- [Alabama](https://isitonrecall.com/state/alabama/)
- [Florida](https://isitonrecall.com/state/florida/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)

## Dates in the source

- **Report date**: Jan 31, 2024
- **Recall initiation date**: Dec 13, 2023
- **Center classification date**: Jan 22, 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-0781-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [SEDECAL SA records](https://isitonrecall.com/brand/sedecal-sa/)