# FDA recall Z-0807-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-12-20.

## Product

Siemens ARTIS pheno, Model # 10849000.  Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

## Reason for recall

The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.

## Distribution

US Nationwide distribution in the states of FL, IL, IN, MA, PA, VA.

## Key facts

- **Recall number:** Z-0807-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-20
- **Report date:** 2020-01-22
- **Termination date:** 2020-05-01

- **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-0807-2020

## Citation

> AI Analytics. FDA recall Z-0807-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0807-2020. Source: US FDA. Licensed CC0.

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