FDA Device Recall Z-0001-2009: Philips Medical Systems North America Co. Phillips

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-2009.

Recall Res Number

Z-0001-2009

Recalling Firm / Manufacturer

Philips Medical Systems North America Co. Phillips

FEI Number

1000524572

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2008-04-10

Date Posted

2009-01-26

Date Terminated

2010-10-29

Product Code

JAA

Event Number

50138

Product Quantity

19 units in the US.

Product Description 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.

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.

Action Details 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.

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

Code Information / Serial Numbers Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002 and NDHR080003.

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Medical Device Recall: Z-0001-2009

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer