—#74807

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.

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K062451, K071308
Affected lot / code info: Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002 and NDHR080003.

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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 (helpdesk@pnms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.

Recalling firm

Firm: Philips Medical Systems North America Co. Phillips
Address: 22100 Bothell Everett Hwy, Bothell, Washington 98021-8431

Distribution

Distribution pattern: Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX.

Timeline

Recall initiated: 2008-04-10
Posted by FDA: 2009-01-26
Terminated: 2010-10-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74807. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.