# FDA recall Z-1958-2020

> **Siemens Medical Solutions USA, Inc** · Class II · device recall initiated 2020-04-20.

## Product

Siemens Cios Alpha VA30-mobile X-Ray system,   Material # 11105200 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

Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session.  If the system displays the error message  Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and  result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector

## Distribution

US Nationwide distributions.

## Key facts

- **Recall number:** Z-1958-2020
- **Recalling firm:** Siemens Medical Solutions USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-20
- **Report date:** 2020-05-20
- **Termination date:** 2021-05-10

- **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-1958-2020

## Citation

> AI Analytics. FDA recall Z-1958-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1958-2020. Source: US FDA. Licensed CC0.

---

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