---
title: "Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system — FDA record Z-0271-2026 | Is It on Recall"
description: "Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions"
url: https://isitonrecall.com/recall/fda-device-z-0271-2026-model-number-sm-40hf-b-d-c-40kw-70c-mobile-x-ray-system/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system — FDA record Z-0271-2026

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 10, 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**: Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray system
- **Reason**: Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- **Classification**: Class II
- **Recalling firm**: SEDECAL SA
- **Quantity**: 181 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0271-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0271-2026%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 08436046001510, Serial Numbers: D11-40KW-F, G36689, G37293, G38198, G38657, G38385, G37687, G36643, G41114, G36137, G36761, G36272, G37188, G37359, G37456, G38178, G62012, G62059, G62892, G62943, G41083, G41100, G36217, G36537, G60066, G61812, G61812, G63322, G40016, G41203, G41222, G60061, G60063, G60064, G36732, G36751, G41119, G62480, G60418, G61707, G65172, G39639, G41104, G36526, G36601, G37129, G37209, G41244, G62015, G40024, G62828, G60429, G61818, G61873, G60065, G61786, G37430, G36148, G39650, G64186, G65400, G64854, G62626, G62660, G62684, G62687, G62747, G62750, G62762, G62938, G63484, G62804, G64206, G64813, G64179, G62500, G62502, G62565, G62690, G62860, G62867, G62883, G62891, G62947, G36222, G60415, G60070, G37646, G61715, G39589, G37466, G38292, G38173, G38058, G38293, G60069, G62816, G63335, G36244, G36492, G37442, G38613, G40124, G40211, G38190, G40199, G62567, G39809, G38287, G37196, G41256, G61872, G62029, G64891, G62682, G62900, G61311, G37239, G38279, G37678, G38076, G61307, G39808, G40133, G62821, G64883, G60058, G60062, G61867, G37676, G40203, G37422, G62815, G36468, G37413, G40216, G41058, G41066, G63212, G41267, G40227, G60430, G63318, G63328, G63333, G41108, G41109, G61716, G60518, G60652, G61356, G60520, G60597, G39800, G39801, G60582, G39657, G62030, G65393, G65395, G39782, G39791, G61706, G61795, G62053, G62062, G62011, G64512, G64520, G65289, G60576, G60606, G60631, G61339, G39465, G61333, G61337, G38629, G62511, G41218, G60635. |

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

## Distribution

US: CA, IL, and NJ

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/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)

## Dates in the source

- **Report date**: Oct 29, 2025
- **Recall initiation date**: Jun 10, 2025
- **Center classification date**: Oct 23, 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-0271-2026%22)

## Related records

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