# FDA recall Z-2887-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-07-30.

## Product

Cios Alpha, Image-Intensified Fluoroscopic X-Ray System    The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.

## Reason for recall

Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after the previous repair of the X-ray Generator with an integrated Energy Storage Unit (ESU).

## Distribution

US Distribution to states of: NC, NE, IL, TX, OH, FL, WI, MN, MD, SC, CA, NY, VA, OK and AZ.

## Key facts

- **Recall number:** Z-2887-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-30
- **Report date:** 2020-09-02
- **Termination date:** 2021-05-20

- **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-2887-2020

## Citation

> AI Analytics. FDA recall Z-2887-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2887-2020. Source: US FDA. Licensed CC0.

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