# FDA recall Z-0523-2024

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2023-10-17.

## Product

ARTIS icono (ceiling configuration), Fluoroscopic x-ray system;  Model no. 11328100

## Reason for recall

Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.

## Distribution

US Nationwide - Worldwide Distribution:  Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX.  Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa

## Key facts

- **Recall number:** Z-0523-2024
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-17
- **Report date:** 2023-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0523-2024

## Citation

> AI Analytics. FDA recall Z-0523-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0523-2024. Source: US FDA. Licensed CC0.

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