FDA-Device2020-01-15Class II
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Hazard
During a routine inspection of a system, a crack on the C-arm holder was discovered. In the event the C-arm holder has a crack, the stability of the C-arm may be compromised and could lead to deformations of the C-arm. In very unlikely cases, an extreme impact to the C-arm such as heavy collision with a wall or table, may lead to a detachment of the C-arm and could potentially result in injury to patients and staff.
Sold states
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WI.
Affected count
190 (updated total of 202 as of 1/20/20)
Manufactured in
40 Liberty Blvd, N/A, Malvern, PA, United States
Products
Cios Alpha, Model Number 10308191; mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical application
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0782-2020More Siemens Medical Solutions USA, Inc recalls
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