Cios Alpha Image-Intensified Fluoroscopic X-Ray System — Class II medical device recall Z-2127-2020

Terminated recall by Siemens Medical Solutions USA, Inc, reported 2020-06-03, distributed nationwide. The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical

Recall number	`Z-2127-2020`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Siemens Medical Solutions USA, Inc, Malvern, PA, United States
Recall initiated	2020-04-17
Classified	2020-05-26
Reported by FDA	2020-06-03
Terminated	2020-08-25
Distributed	Nationwide (US)
Quantity	58
Serial numbers	`10019`, `11200`, `12339`, `12377`, `12618`, `12946`, `12972`, `13045`, `13219`, `13232`, `13241`, `13259`, `13288`, `40013`, `40054`, `40055`, `40057`, `40058`, `40061`, `40062`, `40070`, `40071`, `40073`, `40074`, `40075` and 33 more
Model numbers	`VA20-10308191`, `VA30-10308194`

Product

Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 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

The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2127-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.