Z-2237-2010

NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended...

Name: Z-2237-2010 NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended...
Creator: Neuisys, LLC
Published: 2008-07-21
License: https://open.fda.gov/license/

Neuisys, LLC / initiated 2008-07-21 / Terminated / root cause: software

FDA source

Neuisys, LLC began a recall of NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body... on 2008-07-21. The reason FDA records is "The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode". 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-2237-2010
Status: Terminated
Initiated: 2008-07-21
Posted: 2010-08-19
Terminated: 2010-08-23
Recalling firm: Neuisys, LLC
Product: NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. Intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode.
Root cause tag: software
FDA root cause: Software design
Action: On 07/21/2008, NEUISYS Imaging Systems Solutions distributor in Greensboro, NC began sending the URGENT DEVICE CORRECTION letter on behalf of Philips and NeuSoft Medical Systems (PNMS), Co., Ltd in China. The letter informs the consignees that there is potential safety problem in the NeuViz Dual series CT scanners due to the malfunction of "Incorrect Reference Line in the Film". When a "Head first, Couch out" or a "Feet first, Couch in" Surview scan is started then paused midstream, the image generated is what the doctor expects, but the reference lines appear in the incorrect position in "FILM" display mode. The acquired images accurately represent the exact positions planned on the original view. The incorrect/unmatched reference line in film may result in incorrect diagnosis. The consignees are advised not to stop or pause during Surview acquisition while PNMS in China will provide the updated software patch to all affected systems free of charge. The Field Change Order #FCOP-08-CT-NMS-008 SP4 will be implemented by NEUISYS Imaging Systems Solutions in Greensboro, NC., who is a distributor for PNMS. Consignees are advised to e-mail Service Support Department of PNMS at [email protected] regarding the recall.
Quantity in commerce: 19 units in the US
Distribution: Nationwide Distribution
Product codes and lots: Serial Number: 400562, 400563, 400626, NDH009EI, NDH011El, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR08002, and NDHRO80003.

Product code JAK

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)