# FDA recall Z-1340-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-01-24.

## Product

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

## Reason for recall

Potential exists for one or more axes of the robotic stand to become blocked by their safety brakes;  In the event the axis is blocked by its safety brake, the robotic stand can no longer perform the intended  movements

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1340-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-24
- **Report date:** 2020-02-26
- **Termination date:** 2020-07-10

- **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-1340-2020

## Citation

> AI Analytics. FDA recall Z-1340-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1340-2020. Source: US FDA. Licensed CC0.

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