# FDA recall Z-2019-2025

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2025-05-15.

## Product

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. Procedures that can be performed  with the ARTIS family include cardiac angiography, neuro-angiography, general  angiography, rotational angiography, multipurpose angiography and whole  body radiographic/fluoroscopic procedures as well as procedures next to the  table for i.e., patient extremities. This does not include projection radiography.  Additional procedures that can be performed include angiography in the  operating room, image guided surgery by X-ray, by image fusion, and by  navigation systems. The examination table as an integrated part of the system  can be used for X-ray imaging, surgery and interventions. ARTIS can also  support the acquisition of position triggered imaging for spatial data synthesis.

## Reason for recall

In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

## Distribution

Worldwide.

## Key facts

- **Recall number:** Z-2019-2025
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-05-15
- **Report date:** 2025-07-09

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2019-2025

## Citation

> AI Analytics. FDA recall Z-2019-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2019-2025. Source: US FDA. Licensed CC0.

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