# FDA recall Z-1497-2021

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2021-03-19.

## Product

Interventional Fluoroscopic X-Ray System  ARTIS icono biplane- 11327600  ARTIS icono floor- 11327700  ARTIS pheno- 10849000    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.

## Reason for recall

Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

## Distribution

Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.

## Key facts

- **Recall number:** Z-1497-2021
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-19
- **Report date:** 2021-05-05
- **Termination date:** 2021-11-09

- **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-1497-2021

## Citation

> AI Analytics. FDA recall Z-1497-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1497-2021. Source: US FDA. Licensed CC0.

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