# FDA recall Z-1295-2019

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-03-22.

## Product

Cios Alpha with software version VA30-mobile C-arm x-ray  Material # 11105200    Product Usage:  The Cios Alpha is a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

## Reason for recall

Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radiation emitting components, risk of premature failure of the Monoblock and loss of imaging X-rays exists

## Distribution

US Nationwide Distribution in the states of  NC, MA

## Key facts

- **Recall number:** Z-1295-2019
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-22
- **Report date:** 2019-05-15
- **Termination date:** 2020-05-12

- **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-1295-2019

## Citation

> AI Analytics. FDA recall Z-1295-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1295-2019. Source: US FDA. Licensed CC0.

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