# FDA recall Z-0195-2024

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2023-09-12.

## Product

Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.  11105200

## Reason for recall

Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 systems, fulfillment of new requirements from DIN and IEC standards for Cios VA30 systems required may result in patient misdiagnosis/repeat exposure

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0195-2024
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-12
- **Report date:** 2023-11-08

- **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-0195-2024

## Citation

> AI Analytics. FDA recall Z-0195-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0195-2024. Source: US FDA. Licensed CC0.

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