FDA-Device2020-06-03Class II

Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

Siemens Medical Solutions USA, Inc
Hazard

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.

Sold states
US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.
Affected count
20
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2128-2020

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