FDA-Device2015-07-08Class II

Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

Siemens Medical Solutions USA, Inc
Hazard

under certain circumstances the Cios Alpha system may freeze during a procedure.

Sold states
Nationwide Distribution
Affected count
37
Manufactured in
51 Valley Stream Pkwy, Malvern, PA, United States
Products
Cios Alpha; The Cios Alpha is a mobile X-ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications. Clinical applications may include but are not limited to: interventional fluoroscopic, gastro-intestinal, endoscopic, urologic, pain management, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The patient population may include pediatric patients

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1958-2015

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief