FDA-Device2016-08-17Class II
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Hitachi Medical Systems America Inc
Hazard
The firm discovered that the centrifugal force applied to the power supply may cause it to fail over time. The exam performed at the time of the failure will likely be lost, resulting in the need to rescan the patient.
Sold states
US Distribution to the states of : CA, FL, GA, IA, IL, IN, MD, NC, NY, OH, PA, SD, TN, TX & WY., and Internationally to Brazil and Mexico.
Affected count
33 units
Manufactured in
1959 Summit Commerce Park, Twinsburg, OH, United States
Products
Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America, Twinsburg, OH 44087
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2392-2016Don't want to check this manually?
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