{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "74807", "product_res_number": "Z-0001-2009", "event_date_initiated": "2008-04-10", "event_date_posted": "2009-01-26", "recall_status": "Terminated", "event_date_terminated": "2010-10-29", "res_event_number": "50138", "product_code": "JAA", "k_numbers": [ "K062451", "K071308" ], "product_description": "NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software).\n\nWhole 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.", "code_info": "Serial numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI, NDH034EI, NDHR080001, NDHR080002 and NDHR080003.", "firm_fei_number": "1000524572", "recalling_firm": "Philips Medical Systems North America Co. Phillips", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "425-487-7602", "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_description": "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 (helpdesk@pnms.neusoft.com) or contact Philips Medical Systems North America Co. Phillips at 425-487-7602.", "product_quantity": "19 units in the US.", "distribution_pattern": "Nationwide Distribution --- USA including states of CO, FL, GA, IL, KY, NC, TN and TX.", "openfda": { "k_number": [ "K954590", "K922011", "K902980", "K142341", "K010187", "K233945", "K812775", "K953950", "K902982", "K203010", "K903821", "K926434", "K833237", "K771485", "K103038", "K864584", "K905111", "K962606", "K974058", "K915405", "K902983", "K810716", "K771298", "K882176", "K962140", "K926064", "K004037", "K132904", "K212890", "K861785", "K942841", "K943805", "K924164", "K905278", "K052610", "K896331", "K945460", "K133434", "K173395", "K080859", "K191877", "K951261", "K000987", "K842217", "K801320", "K933472", "K941917", "K922274", "K123097", "K852346", "K884028", "K901405", "K010772", "K182834", "K191713", "K854953", "K770333", "K931268", "K870869", "K911454", "K933100", "K970947", "K051136", "K820184", "K871743", "K942264", "K843920", "K893131", "K973744", "K933473", "K884317", 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