Company: Philips and Neusoft Medical Systems Co., Ltd.
Date of Enforcement Report 5/4/2016
Class lI:
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. Recall Number Z-1573-2016
REASON
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.
RECALLING FIRM/MANUFACTURER
Philips and Neusoft Medical Systems Co., Ltd., Shenyang , China on 3/24/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
73
DISTRIBUTION
NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
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