# FDA recall Z-1469-2023

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2023-03-21.

## Product

ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures.  Material Number: 10848600

## Reason for recall

Examination room monitor connected with the hybrid cable may have a display issue and no image function is available

## Distribution

Worldwide - US Nationwide distribution in the states of FL, SD, PR and the countries of  Angola, Argentina, Australia, Brazil, Bulgaria, China, Georgia, Germany, India, Indonesia,  Iraq, Japan, Malaysia, Morocco, Nepal, Nigeria, Poland, Russia, Rwanda, Serbia, Slovenia, South Africa, Spain, Sudan, Syria, Taiwan, Thailand, Uganda, Ukraine, United Kingdom, Uzbekistan, Vietnam.

## Key facts

- **Recall number:** Z-1469-2023
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-21
- **Report date:** 2023-05-03

- **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-1469-2023

## Citation

> AI Analytics. FDA recall Z-1469-2023. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1469-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*