{ "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": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Waukesha", "state": "WI", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "66459", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "address_2": "", "postal_code": "53188-1615", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belarus, Belgium, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Malaysia, Netherlands, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.", "recall_number": "Z-0373-2014", "product_description": "GE Vivid E9 ultrasound system. GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.", "product_quantity": "710", "reason_for_recall": "GE became aware of a potential safety issue due to a system slow down and system lock up associated with the software of Vivid E9 ultrasound system. During a critical procedure the Vivid E9 Scanner may gradually become unresponsive and eventually lock up, with the result that the vivid E9 Scanner must be rebooted.", "recall_initiation_date": "20131011", "center_classification_date": "20131121", "termination_date": "20150123", "report_date": "20131127", "code_info": "Serial numbers: 0000000VE94166, 0000000VE94167, 0000000VE94170, 0000000VE94171, 0000000VE94172, 0000000VE94173, 0000000VE94174, 0000000VE94175, 0000000VE94176, 0000000VE94177, 0000000VE94178, 0000000VE94179, 0000000VE94180, 0000000VE94181, 0000000VE94182, 0000000VE94183, 0000000VE94184, 0000000VE94185, 0000000VE94186, 0000000VE94187, 0000000VE94188, 0000000VE94190, 0000000VE94191, 0000000VE94192, 0000000VE94193, 0000000VE94194, 0000000VE94195, 0000000VE94196, 0000000VE94197, 0000000VE94198, 0000000VE94199, 0000000VE94210, 0000000VE94211, 0000000VE94212, 0000000VE94213, 0000000VE94214, 0000000VE94215, 0000000VE94216, 0000000VE94217, 0000000VE94225, 0000000VE94226, 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