{ "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": "130967", "product_res_number": "Z-0185-2015", "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": "GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. \r\n\r\nProduct Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.", "code_info": 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"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. \r\n\r\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": "478", "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": [ "K101550", "K201807", "K921008", "K002584", "K940487", "K992731", "K101013", "K924498", "K981352", "K781753", "K210173", "K915470", "K241266", "K161631", "K090811", "K042467", "K013496", "K050366", "K935318", "K161740", "K892358", "K013504", "K180318", "K911078", "K911290", "K894998", "K960948", "K972509", "K992450", "K190900", "K942837", "K011611", "K083649", "K003882", "K010509", "K133657", "K193241", "K962481", "K041022", "K062450", "K221932", "K072567", "K021823", "K210001", "K003434", "K933321", "K141477", "K243186", "K090403", "K922373", "K003849", "K052640", "K033782", "K972686", "K925330", "K940236", "K873775", "K041182", "K130269", "K243538", "K051460", "K022872", "K852239", "K231748", "K040370", "K180514", "K241585", "K240827", "K922426", "K030199", "K171719", 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