# FDA recall Z-0612-2024

> **ARJOHUNTLEIGH POLSKA Sp. z.o.o.** · Class II · device recall initiated 2023-08-29.

## Product

Arjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules

## Reason for recall

Unintended movement of bed wheels

## Distribution

US:  TN, CA, NY, IL, NV, PA, SD

## Key facts

- **Recall number:** Z-0612-2024
- **Recalling firm:** ARJOHUNTLEIGH POLSKA Sp. z.o.o.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-29
- **Report date:** 2024-01-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Komorniki, Poland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0612-2024

## Citation

> AI Analytics. FDA recall Z-0612-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0612-2024. Source: US FDA. Licensed CC0.

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