# FDA recall Z-2748-2018

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2018-06-22.

## Product

ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System    Product Usage:  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. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

## Reason for recall

Potential hardware issue which may cause thermal effects and possible damage to system parts.

## Distribution

US Nationwide Distribution

## Key facts

- **Recall number:** Z-2748-2018
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-22
- **Report date:** 2018-08-22
- **Termination date:** 2020-01-15

- **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-2748-2018

## Citation

> AI Analytics. FDA recall Z-2748-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2748-2018. Source: US FDA. Licensed CC0.

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