# FDA recall Z-1150-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-01-05.

## Product

AXIOM Artis angiographic x-ray system, Model Numbers: 7412807, 7413078, 7728392     AXIOM Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

## Reason for recall

Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.

## Distribution

US Distribution in the following U.S. states: AZ, CA, FL, IA, IL, LA, MI, NC, NJ, OH, OK, and TX.

## Key facts

- **Recall number:** Z-1150-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-05
- **Report date:** 2018-03-28
- **Termination date:** 2018-08-23

- **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-1150-2018

## Citation

> AI Analytics. FDA recall Z-1150-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1150-2018. Source: US FDA. Licensed CC0.

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