# FDA recall Z-1598-2024

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2024-03-21.

## Product

Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models:  Artis zee floor- 10094135  Artis zee ceiling- 10094137  Artis zee multi-purpose- 10094139  Artis zee biplane- 10094141  Artis zeego- 10280959  Artis Q floor- 10848280  Artis Q ceiling- 10848281  Artis Q biplane- 10848282  Artis Q zeego- 10848283  Artis Q.zen floor- 10848353  Artis Q.zen ceiling- 10848354  Artis Q.zen biplane- 10848355  Artis zee floor MN- 10094142  Artis zee biplane MN- 10094143

## Reason for recall

Coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message  TUBE HOT, have a break . the system cannot be operated normally, may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1598-2024
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-21
- **Report date:** 2024-04-24

- **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-1598-2024

## Citation

> AI Analytics. FDA recall Z-1598-2024. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/Z-1598-2024. Source: US FDA. Licensed CC0.

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