FDA-Device2016-06-22Class II
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Siemens Medical Solutions USA Inc.
Hazard
The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
Sold states
Worldwide Distribution - US Nationwide and the countries of China and Malaysia.
Affected count
1 unit
Manufactured in
810 Innovation Dr, Knoxville, TN, United States
Products
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1999-2016Don't want to check this manually?
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