{ "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": "192305", "product_res_number": "Z-0860-2022", "event_date_initiated": "2022-02-18", "event_date_posted": "2022-04-04", "recall_status": "Open, Classified", "res_event_number": "89720", "product_code": "LNH", "k_numbers": [ "K052293", "K121676" ], "product_description": "1.5T and 3.0T SIGNA HDx, 1.5T and 3.0T SIGNA HDxt, and 1.5T SIGNA HDxt Mobile. Magnetic Resonance Imaging System", "code_info": "System IDs: 907562P3T, 256734MR3T, 623879MR1, 623433MR1, 480584MR1, 602689MR1, 9287573TMR, 480324MR1, 480614MR1, 928317MR1, 714868MR1, RADNETMR615, 714619MR, 5107923TMR, 858657MR1, 323442MR3, 323442MR1, 213977MR2, 323932MR1, 323442MR2, RADNETMR612, 650259SM3T, RADNETMR1521, RADNETMR592, 626397MR2, RADNETMR620, 916DR3TMR, 415UCLPMR, 415600D3T, 415476UMR6, 415353MRC1, 415MTZMR, 408GS3TMR, RADNETMR1595, 408885MR3T, RADNETMR608, 805569MR, 415723SHMR8, 661AIMR2, RADNETMR594, 805CHLIMR1, 720848MR2, 303340MR, 030022MR01, 515282MR1, 859275MR3T, 2709263HD, 504873TMR3, 504DISWMR, 504DISMR3T, BEV3TMR, 9786823T, RADNETMR1659, RADNETMR1589, 207MMCSMR, 517353VH3, 269342MR3T, 269342MR3T2, 517374MR3T, 248465MR3T, 248849MR3T, 662MSU3T, 406751K3T, CONCORD3T, 201669MR2, 716859MR3T, NYP347652, 212305MR83T, 5857853T, 631686MR3T, 5853413TLAC, 419383MR3T, 503280MR2, 6109883TMR, 423844MR2, 865541MR3T, 615777MR3T, 936441MR1, 817882H3TMR, 513556MR, 713441MR5, 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YM1882, YM1813, YM1812, YM1850, YM1823, YM1843, YM1810, YM1845, YM1820, YM2018, YM1400, YM0796, YM0790, YM1870, YM0888, YM3042, YM1804, YM1880, YM1877, YM2003, YM1808, YM0802, YM1411, YM1798, YM1819, YM1809, YM1822, YM0801, YM1848, YM1828, YM1844, YM1792, YM1793, YM1402, YM1818, YM2020, YM1824, YM1846, YM0791, YM1879, YM1399, YM1826, YM1849, YM1847, YM3939, YM0872, YM2005, YM1827, YM1803, YM2012, YM1835, YM1816, 850270200, 850270202, 850270333, 850270220, LB1000MR02, 2716757SIGNAHX, 920279024, PL3800MR01, PL3545MR01, PL1050MR01, PL3040MR01, PL3546MR01, PER28007, 787641HDXT, RO1189MR01, RU1588MR01, RU1087MR01, RU1089MR04, RU1067MR02, RU1688MR01, RU9155MR02, RU1884MR01, SA1012MR01, SA1001MR03, RS4202MR01, SI4024MR02, ZA2169MR01, DEL26444, CEN03406, DPC79014, DEN51500, NPV84502, G002MR01, SY2012MR02, 0853270074, 0853270095, 0853270081, 0853270094, 0853270088, AE1190MR01, 70328MRS04", "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": "GE Healthcare Service\n800-437-1171", "reason_for_recall": "There is potential for the images to be flipped left to right.", "root_cause_description": "Device Design", "action": "This issue will be resolved by sending an Urgent Medical Device Correction letter to customers with affected systems. This 2/18/2022 letter informs the customer of the issue and provides actions to be taken for the continued use of the device. GE Healthcare will provide a revised service manual that includes a required Finalization step that ensures a geometry check with a DQA phantom (or similar) following Gradient Switch servicing to ensure cable placement is correct and will have no impact on image orientation. A second letter was send to customers on 07/27/2022 and included instructions and link for customer to access and download the revised service manual.", "product_quantity": "653 units", "distribution_pattern": "Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador, Ethiopia, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Italy, Japan, Korea, Kuwait, Lebanon, Mexico, Netherlands, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Turkey, United Arab Emirates, and United Kingdom.", "openfda": { "k_number": [ "K253808", "K241331", "K915395", "K033168", "K893881", "K230187", "K903527", "K921046", "K943189", "K935015", "K943440", "K230972", "K982959", "K072237", "K934514", "K202966", "K902310", "K915112", "K032678", "K162183", "K934485", "K903048", "K092469", "K910817", "K900286", "K011485", "K230355", "K143128", "K243667", "K040877", "K232535", "K964753", "K183274", "K901242", "K172685", "K010057", "K896508", "K961969", "K902316", "K970037", "K041476", "K052078", "K041111", "K192851", "K171778", "K893675", "K223439", "K250436", 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