{ "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": "140633", "product_res_number": "Z-0257-2016", "event_date_initiated": "2015-08-31", "event_date_posted": "2015-11-10", "recall_status": "Terminated", "event_date_terminated": "2018-09-07", "res_event_number": "72301", "product_code": "LNH", "k_numbers": [ "K041476" ], "product_description": "GE Healthcare, SIGNA HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.", "code_info": "002005-1018-15\t352333MR3T 000006-0523-13\t716859MR3T 00001003BD6425\t352376MR3T2 00000280001MR9\tMR129031 00000285499MR0\t2154563TMR 000000HDMR3702\tRADNETMR554 00000274930MR7\t805CHLIMR1 00000280057MR1\t513558MR3T 00000274998MR4\t213977MR2 002004-0713-06\tACB41109MR 002004-0406-08\t323442MR2 002004-0406-15\t323442MR1 00000273396MR2\t7326133T 002004-1115-19\t865373MR1 002005-0316-05\t7576713T 0002005-0606-4\t205750MR2 00000274839MR0\t9287573TMR 002006-0119-15\t559325CIIMR1 0002005-1201-3\t256734MR3T 002005-1003-15\t201487MR 000000HDMR2996\t6053223TMR 000000HDMR3245\t775RDC3T 002005-0620-16\t405634S3T 00000269460MR2\t602406IMR 00000275670MR8\t813972VAMR 0002005-1121-7\t480614MR1 00000273230MR3\t602689MR1 002005-1201-20\t601288MR3T 00000275936MR3\tALLIANCESIG463 00000275086MR7\t650306SMR3T 00000275162MR6\t772VRAMR3T 00000273459MR8\t360397MR2 0002005-0104-5\t662841MR4 000006-0511-20\t336852SEMR 00000278626MR7\t228KAFBMR3T 00000278619MR2\t806212MR3T 00000278722MR4\t337261MR1 00000281703MR9\t916DR3TMR 0002005-0511-5\t203797MR3T 002005-1115-04\t615342MR3T 00000282868MR9\t504873TMR3 00000281682MR5\t859275MR3T 000000HDMR5653\tRADNETMR608 00000000036657\t480584MR1 #N/A\tTRAINING789 N/A\t201669MR2 00000278623MR4\t972378NSC3TMR1 00000267322MR6\t920568MR3T 00000273365MR7\t503280MR2 0002005-1201-6\t865541MR3T 00000086257DP3\t901516U3T 00000264748MR5\t0910277003 00000268123MR7\t0910272046 \tAZ1003MR02 00000282790MR5\t082427090245 00000285380MR2\t082427100084 00000286559MR0\t082427090090 00000286800MR8\t082427100089 00000287879MR1\t082427040076 00000288667MR9\t082427070050 00000289798MR1\t082427100093 00000261198MR6\t082427210039 00000262803MR0\t082427070034 00000262931MR9\t082427040047 00000265593MR4\t082427160041 00000266147MR8\t082427040061 00000267973MR6\t082427040052 00000270974MR9\t082427100064 00000271233MR9\t082427040046 00000272894MR7\t082427140039 00000273229MR5\t082427120044 00000277189MR7\t082427160049 290392MR0¿¿¿¿¿¿¿¿¿¿ \t082427270017 00000265589MR2\tDK1083MR04 00000000WB0692\tET1009MR01 00000262460MR9\t0828270021IB01 00000270245MR4\t0828270023 00000272433MR4\t083027002101706 N/A\t083027202101396 00000275668MR2\tIR1503MR01 00000279077MR2\tKW1004MR03 00000262791MR7\t56MRE3TH2565370 00000280669MR3\t0920279025 00000309597MR3\tNO1011MR01 00000272533MR1\t787840CIRT3T 00000276591MR5\t787653MR3T 00000279460MR0\t787740MR3T 00000275845MR6\tRU1283MR01 00001002BD637F\tMEX68900 00000HDMR10201\tGP178328 00000275642MR7\tGEE34040 000000000WB658\tMPX10000 00000266820MR0\t387040MR06 00000262456MR7\t34208MRS01 00000271120MR8\t34006MRS03 00000266270MR8\t10146MRS03 00000274693MR1\t3882630908MRMET", "firm_fei_number": "2126677", "recalling_firm": "GE Healthcare", "address_1": "3000 N Grandview Blvd", "city": "Waukesha", "state": "WI", "postal_code": "53188-1615", "additional_info_contact": "GE Healthcare Service\n800-437-1171", "reason_for_recall": "When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.", "root_cause_description": "Software design", "action": "GE Healthcare sent an Urgent Medical Device Correction letter dated August 31, 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.", "product_quantity": "97", "distribution_pattern": "Worldwide Distribution - US: Nationwide including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.", "openfda": { "k_number": [ "K241607", "K063559", "K944469", "K901620", "K170090", "K213305", "K893881", 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