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…

Recall date

March 24, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1573-2016

FDA classification

Class II

Brand / firm

Philips and Neusoft Medical Systems Co., Ltd.

Sold / distributed

NC, OH, NE, SC, TX, LA, PR, MO, FL, CT

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.