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Philips and Neusoft Medical Systems Co., Ltd. recalls NeuViz 16 Multi-Slice CT Scanner System PN: 989605858501 a whole body computed tomography X-ray system featuring a cont
Recalled May 4, 2016 · FDA recall Z-1573-2016 · Philips and Neusoft Medical Systems
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 · FDA Class II
Units
37 units
Sold at
NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
Description
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
Product
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.
Manufacturer(s)
Philips and Neusoft Medical Systems Co., Ltd.
Made in
China
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →