---
title: "5008X CAREsystem +CLiC +CDX; — FDA record Z-0936-2026 | Is It on Recall"
description: "Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditio"
url: https://isitonrecall.com/recall/fda-device-z-0936-2026-5008x-caresystem-clic-cdx/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# 5008X CAREsystem +CLiC +CDX; — FDA record Z-0936-2026

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 Oct 25, 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**: 5008X CAREsystem +CLiC +CDX;
- **Reason**: Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
- **Classification**: Class II
- **Recalling firm**: Fresenius Medical Care Holdings, Inc.
- **Quantity**: 115 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0936-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0936-2026%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 | Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4; |

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

## Distribution

Domestic: LA, MA, MN;

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

- [Louisiana](https://isitonrecall.com/state/louisiana/)
- [Massachusetts](https://isitonrecall.com/state/massachusetts/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)

## Dates in the source

- **Report date**: Dec 24, 2025
- **Recall initiation date**: Oct 25, 2025
- **Center classification date**: Dec 17, 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-0936-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Fresenius Medical Care Holdings, Inc. records](https://isitonrecall.com/brand/fresenius-medical-care-holdings-inc/)