# FDA recall Z-0614-2018

> **Siemens Medical Solutions USA, INC** · Class II · device recall initiated 2017-08-22.

## Product

Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus

## Reason for recall

The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen

## Distribution

US Distribution to the states of :  AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.

## Key facts

- **Recall number:** Z-0614-2018
- **Recalling firm:** Siemens Medical Solutions USA, INC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-08-22
- **Report date:** 2018-02-21
- **Termination date:** 2018-08-21

- **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-0614-2018

## Citation

> AI Analytics. FDA recall Z-0614-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0614-2018. Source: US FDA. Licensed CC0.

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