# FDA recall Z-0298-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-09-21.

## Product

Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model:  10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.

## Reason for recall

Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).

## Distribution

US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, IN, LA, MI, MO, NC, NJ, NY, PA, TX, WA.

## Key facts

- **Recall number:** Z-0298-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-21
- **Report date:** 2020-11-04
- **Termination date:** 2021-08-03

- **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-0298-2021

## Citation

> AI Analytics. FDA recall Z-0298-2021. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0298-2021. Source: US FDA. Licensed CC0.

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