Z-0001-2009

NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed...

Name: Z-0001-2009 NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed...
Creator: Philips Medical Systems North America Co. Phillips
Published: 2008-04-10
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-04-10 / Terminated / root cause: software

FDA source

Philips Medical Systems North America Co. Phillips began a recall of NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software). Whole body x-ray computed tomography scanner which features a continuously rotating... on 2008-04-10. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0001-2009
Status: Terminated
Initiated: 2008-04-10
Posted: 2009-01-26
Terminated: 2010-10-29
Recalling firm: Philips North America LLC
Product: 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.
Product code: JAA System, X-Ray, Fluoroscopic, Image-Intensified
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.
Root cause tag: software
FDA root cause: Software design
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.
Quantity in commerce: 19 units in the US.
Distribution: Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX.
Product codes and lots: Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002 and NDHR080003.

Product code JAA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)