# FDA recall Z-2240-2024

> **Siemens AG/Siemens Healthcare GmbH** · Class II · device recall initiated 2024-06-26.

## 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.

## Reason for recall

A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

## Distribution

Worldwide - US Nationwide distribution in the states of TX, MA, NH, MN, OK, NJ, SC, NY, MI, IL, MO, NC.

## Key facts

- **Recall number:** Z-2240-2024
- **Recalling firm:** Siemens AG/Siemens Healthcare GmbH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-26
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** FDA Mandated
- **Location:** Forchheim, N/A, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2240-2024

## Citation

> AI Analytics. FDA recall Z-2240-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2240-2024. Source: US FDA. Licensed CC0.

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