{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "130972", "product_res_number": "Z-0188-2015", "event_date_initiated": "2014-10-14", "event_date_posted": "2014-12-16", "recall_status": "Terminated", "event_date_terminated": "2015-02-27", "res_event_number": "69570", "product_code": "KPS", "k_numbers": [ "K022960", "K052434", "K991841" ], "product_description": "Optima NM/CT 640, Models H3100YA, H3100YC. \n\n Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies", "code_info": "25018\t816234D640 26004\t815564O640 26007\t817250NM640 26010\t717782640NM 26012\t808485NM640 26013\t847872O640 26014\t901516GO640 26018\t270956NM640 26020\t309672NM2 26021\t215728OPT640 26025\t410543NUC640 26026\t928214NMCT 26028\t715735OPT1 26002\t0910263256 26005\t0910263253 22020\t030232NU15 26009\tDK1054NM03 26001\tXM203401 26003\tULUE01NU02 26015\t915839NU01 26024\t083026800008113 26006\tA5639613 26008\tA5366308 25023\tRTD0782 26030\tNM26030 26023\tBD003NU01 26017\t00162NUC11 26019\t00203NUC06 26022\t00139NUC08", "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": "800-437-1171", "reason_for_recall": "GE is issuing this recall due to a potential safety issue related to a portion of the system falling onto the patient during a scan due to fasteners being loose that secured the camera to the gantry. GE is updating the Preventative Maintenance procedure and schedule, and added an additional Preventative Maintenance check for loose fasteners on the Nuclear Medicaine systems.", "root_cause_description": "Nonconforming Material/Component", "action": "The firm, GE Healthcare, sent an \"URGENT MEDICAL DEVICE CORRECTION\" letter, GEHC Ref# 40860, dated October 14, 2014 to its consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, actions to be taken and Contact Information. \n\nFor questions, consignees in the United States, can contact 1-800-437-1171, for other countries they can contact their GE Healthcare Service Representative.", "product_quantity": "29", "distribution_pattern": "Worldwide Distribution: US (nationwide) including Guam, Puerto Rico and DC; and countries of: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BELRARUS, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, GREECE, GUADELOUPE, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MALTA,MARTINIQUE, MEXICO, MOROCCO, NAMIBIA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN,SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, URUGUAY, VENEZUELA, VIET NAAM.", "openfda": { "k_number": [ "K013504", "K113448", "K031705", "K001276", "K073021", "K926133", "K240827", "K011572", "K131634", "K251370", "K963273", "K110507", "K261315", "K790169", "K130269", "K243186", "K781753", "K161740", "K000908", "K043293", "K050366", "K942146", "K231748", "K061587", "K994167", "K014033", "K140206", "K923736", "K081496", "K130451", "K101768", "K862511", "K912573", "K953193", "K040370", "K132347", "K963162", "K041955", "K992450", "K023932", "K042258", "K980914", "K041671", "K954129", "K090553", "K923151", "K080784", "K140651", "K945721", "K914179", "K964268", "K982171", "K964712", "K231833", "K991896", "K192277", "K925186", "K051549", "K973233", "K810589", "K182336", "K033254", "K200474", "K041166", "K083852", "K141652", "K926206", "K914267", "K081201", "K961597", "K982387", "K210262", 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