Neuisys, LLC 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Neuisys, LLC
Lot Codes / Batch Numbers
Serial Number: 400562, 400563, 400626, NDH009EI, NDH011El, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR08002, and NDHRO80003.
Products Sold
Serial Number: 400562, 400563, 400626, NDH009EI, NDH011El, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR08002, and NDHRO80003.
Neuisys, LLC is recalling NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321 due to The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The reference lines for image generated for a Surview scan may appear in the incorrect position in the "FILM" display mode.
Recommended Action
Per FDA guidance
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 helpdesk@pnms.neusoft.com regarding the recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026