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Siemens Medical Solutions USA, Inc recalls Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The Cios Alpha is a mobile X-Ray system designed
Recalled May 15, 2019 · FDA recall Z-1298-2019 · Siemens Medical Solutions USA
Hazard
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays. · FDA Class II
Units
257
Sold at
US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Description
Continuous operation at very high tube output may result in increased wear of the radiation emitting components. This may occur when tube voltages of 125 kV are used for a long period, e.g. 30 minutes or more of continuous use. As a result, risk of premature failure of the Monoblock and loss of imaging X-rays.
Product
Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: 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.
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →