FDA-Device2015-08-12Class II
Biograph mCT Flow Edge-4R, Model Number 10528955
Siemens Medical Solutions USA Inc.
Hazard
Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.
Sold states
Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.
Affected count
3 units
Manufactured in
810 Innovation Dr, N/A, Knoxville, TN, United States
Products
Biograph mCT Flow Edge-4R, Model Number 10528955
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2015Don't want to check this manually?
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