{ "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": "149267", "product_res_number": "Z-0201-2019", "event_date_initiated": "2015-12-07", "event_date_posted": "2015-12-28", "recall_status": "Terminated", "event_date_terminated": "2018-11-08", "res_event_number": "72892", "product_code": "LNH", "k_numbers": [ "K081028", "K132376", "K142085", "K142361" ], "product_description": "GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.", "code_info": "Mfg Lot or Serial #\tSystem 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"firm_fei_number": "2183553", "recalling_firm": "GE Medical Systems, LLC", "address_1": "3200 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1693", "additional_info_contact": "GE Healthcare Service\n262-521-6560", "reason_for_recall": "GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners.\n\nCoil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.\n\nUPDATE 5/27/2016: Recall has been updated to include an additional product which includes the Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.", "root_cause_description": "Nonconforming Material/Component", "action": "Consignees were sent on 12/7/2015 a GE Healthcare \"Urgent Medical Device Correction\" GEHC Ref#60888 letter dated December 7, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Department Managers, Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.\n\nUPDATE: Consignees were sent a revised letter on May 2, 2016. Previously the letter only listed MR750W Surgical Suite Scanners. Because 3.0T 6 Channel Flex Coils are used with the MR750, MR750W, and 3.0T HDxT (including HD23), these devices have been added to the letter. There are no other changes to the letter.\n\nUPDATE 5/27/16: Consignees were sent a revised letter on May 19, 2016. The letter topic stated \"De-rating of 3.0T 6 Channel Flex Coil when used on Discovery MR750 running DV24, DV25, or DV25.1 Application Software\" . The letter described the Safety Issue, Safety Instruction, Affected Product details, Product Correction and Contact Information (same as previous letter).", "product_quantity": "356 (98 US; 258 OUS)", "distribution_pattern": "Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM, INDONESIA, ESTONIA, REPUBLIC OF KOREA, POLAND, KUWAIT, SPAIN.", "openfda": { "k_number": [ "K253489", "K072473", "K111803", "K222968", "K121160", "K900289", "K253648", "K902310", "K921653", "K122613", "K003899", "K183254", "K261331", "K251397", "K933296", "K151579", "K243547", "K910817", "K171778", "K923581", "K040444", 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