{ "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": "94574", "product_res_number": "Z-0369-2011", "event_date_initiated": "2010-09-03", "event_date_posted": "2010-11-15", "recall_status": "Terminated", "event_date_terminated": "2012-05-15", "res_event_number": "56814", "product_code": "JAK", "k_numbers": [ "K052855", "K082761", "K082816" ], "product_description": "GE BrightSpeed Excel/Edge/Elite Select / Elite CT Scanner System, models 2377708-560, 5377708-540, 5377708-560. Composed of a gantry, patient table, operator console, computer, and PDU and includes image acquisition hardware, image acquisition and reconstruction software, associated accessories and connections/interfaces to accessories. \n\nIs intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), Cardiac, and Gated acquisitions.", "code_info": "Model 2377708-560, serial numbers: 00000018952YC2. 00000018953YC0. 00000018954YC8. 00000019505YC7. 00000019506YC5. 00000019507YC3. 00000019508YC1. 00000019509YC9. 00000019663YC4. 00000019664YC2. 00000019665YC9. 00000019772YC3. 00000019773YC1. 00000019898YC6. 00000019899YC4. 00000020095YC6. 00000020147YC5. 00000020277YC0. 00000020278YC8. 00000020708YC4. 00000020709YC2. 00000020710YC0. 00000020835YC5. 00000020888YC4. 00000020936YC1. 00000020937YC9. 00000021104YC5. 00000021105YC2. 00000021106YC0. 00000021286YC0. 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"53188-1615", "additional_info_contact": "Call Center\n800-437-1171", "reason_for_recall": "GE has become aware of a potential set of circumstances that could cause x-ray continuation during an unexpected table stop on certain LightSpeed VCT and BrightSpeed systems.", "root_cause_description": "Software design", "action": "An Urgent Medical Device Correction letter dated September 2, 2010 was sent to consignees beginning September 3, 2010. This letter addressed the LightSpeed VCT systems. Another Urgent Medical Device Correction letter, dated September 24, 2010 was sent September 24, 2010 for the BrightSpeed Systems. The letters described the issue and provided safety instructions for the health care provider to be aware if the table should stop unexpectedly and the x-ray remains on to manually stop the scan until the devices software is upgraded.\n\nIf you have any questions, please contact the US (800) 437-1171, Japan 0120-055-919, Korea 1544-6119, Australia/New Zealand 800 659 465, China 800-810-8188; for other countries, please contact your local GE Healthcare Services Representative.", "product_quantity": "946", "distribution_pattern": "Worldwide distribution: USA including states of: MI, NM, OH, TX, and Puerto Rico and countries including: Algeria, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hungary, India, Indonesia, Ireland, Islamic Republic of Iran, Israel, Italy, Jamaica, Japan, Kenya, Lebanon, Malaysia, Mauritania, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Pakistan, Paraguay, Philippines, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.", "openfda": { "k_number": [ "K173478", "K233650", "K082960", "K133590", "K170238", "K811358", "K880822", "K250970", "K250662", "K143409", "K912752", "K133640", "K183161", "K911764", "K000300", "K033418", "K123540", "K091529", "K220986", "K011141", "K190505", "K242403", "K020385", "K872615", "K200515", "K151673", "K993791", "K081022", "K864046", "K053610", "K221116", "K163643", "K061817", "K192590", "K193170", "K163296", "K233753", "K102259", "K120796", "K191550", "K882022", "K780769", "K192686", "K923106", "K870513", "K130901", "K133674", "K142222", "K082104", "K961464", "K181646", "K083524", "K151765", 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"device_name": "System, X-Ray, Tomography, Computed", "medical_specialty_description": "Radiology", "regulation_number": "892.1750", "device_class": "2" } } ] }