NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is an interactive program used for x-ray scan control, image reconstruction, and image archive/evaluation. It is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles. The function of Time Scan is intended to use in contrast scan include single phase and multi-phase scan, that is according to different density of contrast in vessels or organs between different phase to get necessary information to support doctor's diagnosis.
FDA Recall Z-0001-2009 · Posted 2009-01-26
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Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeJAA
Date Initiated2008-04-10
Date Terminated2010-10-29
Product Quantity19 units in the US.
Reason for Recall
An issue associated with the "Timed Scan" application was found. The system does not wait for the programmed time interval and starts the x-ray after selection of the scan button when certain criteria is met.
Firm Action
A letter was issued to customers prior to the release of the field correction during June 2008. The system software will be updated to correct the non-compliances. For information or support concerning this issue, please contact the Neusoft Medical Systems Service Support Department ([email protected]) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.
Root Cause
Software design
Distribution Pattern
Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX.
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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