# FDA recall Z-2108-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-04-22.

## Product

ARTIS Pheno - Interventional Fluoroscopic X-Ray System  Model: 10849000 - Product Usage: 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

If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2108-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-22
- **Report date:** 2020-06-03
- **Termination date:** 2020-10-09

- **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-2108-2020

## Citation

> AI Analytics. FDA recall Z-2108-2020. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-2108-2020. Source: US FDA. Licensed CC0.

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