# FDA recall Z-0782-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2019-11-25.

## Product

Cios Alpha, Model Number 10308191;  mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application

## Reason for recall

During a routine inspection of a system, a crack on the C-arm holder was discovered.  In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.

## Distribution

US Nationwide distribution in the states of  AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

## Key facts

- **Recall number:** Z-0782-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-25
- **Report date:** 2020-01-15
- **Termination date:** 2020-05-06

- **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-0782-2020

## Citation

> AI Analytics. FDA recall Z-0782-2020. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0782-2020. Source: US FDA. Licensed CC0.

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