# FDA recall Z-2359-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2023-06-19.

## Product

ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.  Material Number: 11327600

## Reason for recall

Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system

## Distribution

Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria,  Belgium, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe,  Hong Kong, India, Indonesia, Italy, Japan, Latvia, Luxembourg, Macedonia, Mexico,  Monaco, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Slovakia, Slovenia,  South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

## Key facts

- **Recall number:** Z-2359-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-19
- **Report date:** 2023-08-16

- **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-2359-2023

## Citation

> AI Analytics. FDA recall Z-2359-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2359-2023. Source: US FDA. Licensed CC0.

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