{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "121897", "product_res_number": "Z-0021-2014", "event_date_initiated": "2013-08-16", "event_date_posted": "2013-10-17", "recall_status": "Terminated", "event_date_terminated": "2014-05-30", "res_event_number": "66254", "product_code": "OWB", "k_numbers": [ "K022322", "K023178", "K945375", "K960575", "K974367", "K993037" ], "product_description": "GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ.\n\nIntended for general purpose diagnostic fluoroscopy and radiography studies.", "code_info": "Mfg Lot or Serial #\tSystem 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info\t8183MLCLHU No susp info\t9926LCPLUS No susp info\tLCV+61055 No susp info\t0920TESTEQUIP No susp info\tPK1183VA01 No susp info\t21XR59740 No susp info\t38223341XR No susp info\t38239075LCV No susp info\tADOMEDVA01 No susp info\t787620IN4100 No susp info\t809269LCA No susp info\t809852INNOVA No susp info\tRO4165VA01 No susp info\tRU1041DM01 No susp info\tRU1195RX01 No susp info\tYU4060VA01 No susp info\tC99999164 No susp info\tDE539251 No susp info\tFA49RX02 No susp info\tFA57RX02 No susp info\tFA82RX02 No susp info\tNO003RX01 No susp info\t0853060149 No susp info\t34107VAS01 No susp info\tGE001VAS01 No susp info\t10238VAS01 No susp info\t388200-1XRAND No susp info\t3882569347VAMET No susp info\t388256938VASMET No susp info\t388308XRAND No susp info\t38839419VASMET", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare, LLC", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "262-513-4122", "reason_for_recall": "GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems.", "root_cause_description": "Process control", "action": "Consignees were sent on 8/12/2013 a GE Healthcare \"Urgent Medical device Correction\" letter dated August 12, 2013. The letter was addressed to Hospital Administrators / Risk Mangers, Mangers of Radiology /Cardiology /Surgery Department and Radiologists /Cardiologists /Surgeons.\n\nThe letter described the Safety Issue, safety Instructions, Affected Product details, Product Correction and Contact Information (US 800-437-1171, Japan 0120 055 919).", "product_quantity": "2184 (1063 US. 1121 OUS)", "distribution_pattern": "Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and except ND, SD and VT, and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA ARICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY,GREECE, GUADELOUPE, GUATEMALA, HONDURAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN,IRELAND, ITALY, JAMAICA, JAPAN,JORDAN, KAZKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LIBYA ARAB JAMHIRIYA, LITHUANIA, MALAYSIA MALTA, MARTINIQUE, MEXICO, MOROCCO, 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