FDA-Device2016-05-04Class II
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 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 following issues are found in NeuViz 16 systems with software version 1.1.4.21425 and version 1.1.4.21426: 1) During the filming operation on MX 16-slice console software, the clipboard used for copying and pasting images is not cleared between patients. If the operator fails to copy the current patient's images before pasting, a previous patient's image may be present in the clipboard and be
Sold states
NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
Affected count
37 units
Manufactured in
No. 2 Xiu xiu Street, Hunnan; Sujiatun, Shenyang, N/A, China
Products
NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 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-1573-2016Don't want to check this manually?
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