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.
FDA Recall Z-1573-2016 · Posted 2016-04-27
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Recalling FirmPhilips and Neusoft Medical Systems Co., Ltd.
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-03-24
Date Terminated2016-11-23
Product Quantity37 units
Reason for Recall
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
Firm Action
Affected consignees will be notified of the recall via letter on March 24, 2016. Mandatory Field Change Order and FCO kits will be released to all affected systems in June, 2016.
Root Cause
Under Investigation by firm
Distribution Pattern
NC, OH, NE, SC, TX, LA, PR, MO, FL, CT
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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