FDA-Device2012-12-12Class II
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Philips And Neusoft Medical Systems Co., Ltd.
Hazard
The four screws that secure the patient table top to the carrier pulled out and caused the table top to detach. This issue may affect NeuViz Dual and NeuViz 16 scanners.
Sold states
Nationwide Distribution including North Carolina, Ohio, Texas, and Puerto Rico.
Affected count
20 units of NeuViz 16 CT Scanner Systems and 25 units of NeuViz Dual series
Manufactured in
16 Century Road, Neusoft Park,, Hun Nan Industrial Area, Shenyang, Liaoning, N/A, China
Products
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0466-2013Don't want to check this manually?
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