{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "208749", "product_res_number": "Z-2373-2024", "event_date_initiated": "2024-06-13", "event_date_posted": "2024-07-16", "recall_status": "Open, Classified", "res_event_number": "94905", "product_code": "KGI", "k_numbers": [ "K023398" ], "product_description": "Horizon X-Ray Bone Densitometer (DXA)\n\nModels: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN", "code_info": "Lot Code: \nModel Horizon A; UDI 15420045505384\nModel Horizon C; UDI 15420045505698\nModel Horizon CI; UDI 15420045505827\nModel Horizon W; UDI 15420045505834 \nModel Horizon WI; UDI15420045505865.\n*****UPDATE 8/16/24***\nUS Serial 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"firm_fei_number": "3005496266", "recalling_firm": "Hologic Inc", "address_1": "600 Technology Dr", "city": "Newark", "state": "DE", "postal_code": "19702-2463", "additional_info_contact": "Skeletal Health Customer Support\n+1-877-3714372", "reason_for_recall": "Non-conformance pertains to electromagnetic compatibility requirements according to the international technical standard IEC 60601-1-2 for the safety and essential performance of medical electrical equipment, where the result from the Horizon DXA System exceeded the limit for acceptability.", "root_cause_description": "Under Investigation by firm", "action": "***August 16, 2024 UPDATE***\nAfter further review of the install base for systems in scope of the Horizon recall, updates made to the consignee list. From the original list, 270 systems have been identified to be out of scope of this recall. Additionally, 44 systems were identified to be in scope of the recall that were not on the original consignee list. Customer notifications for the additional 44 in scope systems were distributed on 8/13/2024. RES Updated Serial numbers.\n\n\nHologic issued URGENT: MEDICAL DEVICE CORRECTION FA-00247 Letter on 6/26/24.\nLetter states reason for recall, health risk and action to take:\nRecommendations:\n\" Do NOT scan patients that have active implanted medical devices, including but not limited to neurostimulators, pacemakers, cardiac defibrillators, continuous glucose monitors, or other bio-wearable sensors.\n\" Any operator who has an active implanted medical device should also refrain from operating the system at this time.\n\" Do NOT scan patients that are currently being treated with an electronic medical \ndevice.\n\" Extend this communication to all pertinent staff in interaction and/or use with the Horizon DXA System.\n\" Until the correction is completed, this letter and the specific warning below supersedes information provided on the Horizon DXA labeling and IFU pertaining to electromagnetic compatibility and electromagnetic interference.\nRectification activity by Hologic:\nWe are urgently investigating the permanent rectification actions required, and we will be in contact promptly once this is defined. A service appointment will be scheduled for the remediation activity.\nAs additional clarification regarding the continued safe use of your Horizon DXA system, please note the following:\nThis notice pertains to electromagnetic emissions, not ionizing radiation. Electromagnetic emissions are emitted by all electronic devices, such as cell phones, lights, computers, TVs, medical devices, among others.\n\nFurther, please note that elec", "product_quantity": "2,642 units (1037 units US; 1605 units OUS)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of India, Australia, Spain, Estonia, Germany, Italy, Canada, Thailand, Dominican Republic, Portugal, Islas Canarias, \nAndorra, Switzerland, Taiwan, Austria, Korea, Republic of Philippines, Kuwait, Slovakia, \nChina, Belgium, Ireland, United Kingdom, Malaysia, Palestinian Territory, Occupied, Peru, Singapore, Qatar, Algeria, Pakistan, New Zealand, Croatia, Brazil, Bangladesh, \nSaudi Arabia, Venezuela, Israel, Lebanon, Nepal, Romania, Greece, Hong Kong, Morocco, \nIndonesia, Cyprus, Jordan, France, Mexico, Colombia, Iran, Islamic, Republic of Chile, \nTurkey, Uruguay, Viet Nam, Serbia, Poland, Japan, Malta, Netherlands, South Africa.", "openfda": { "k_number": [ "K961011", "K001429", "K913321", "K963789", "K901857", "K243218", "K213760", "K894854", "K953032", "K152299", "K003656", "K030962", "K884625", "K945526", "K926300", "K130277", "K113616", "K023554", "K844835", "K891582", "K113356", "K140342", "K220402", "K071570", "K060111", "K030330", "K972517", "K964562", "K072439", "K926019", "K972882", "K091325", "K973104", "K072664", "K191112", "K792444", "K973459", "K242295", "K992775", "K961787", "K011917", "K983273", "K983271", "K943505", "K113286", "K002113", "K001812", "K931996", "K984178", "K941127", "K042480", "K881865", "K914404", "K810159", "K902959", "K915535", "K133664", "K871446", "K041266", "K072847", "K103730", "K970224", "K880404", "K934040", "K901848", "K802180", "K103265", "K992246", "K080711", "K881383", "K023398", "K883360", "K982267", "K983724", "K950611", "K002500", "K000162", "K000826", "K810140", "K941126", "K082317", "K863618", "K992125", "K033224", "K861233", "K896677", "K952060", "K254072", "K904980", "K980569", "K841463", "K905691", "K873296", "K033550", "K802181", "K972053", "K113725", "K941362", "K905291", "K252718", "K161682", "K890121", "K890999", "K864299", "K901832", "K901854", "K021331", "K993337", "K894795", "K061561", "K963363", "K861515", "K964263", "K980125", "K993176", "K913078", "K883280", "K251022", "K843922", "K983269", "K983028", "K082402", "K971735", "K961944", "K001756", "K844766", "K922286", "K852509", "K052581", "K220822", "K002711", "K992677", "K984285", "K901804", "K031991", "K180782", "K021527", "K961007", "K983564", "K871553", "K852510", "K981124", "K121716", "K964307", "K980289", "K905753", "K974437", "K983262" ], "registration_number": [ "3010687441", "3019373577", "3008921184", "3008496839", "3023003446", "2183066", "9616391", "3010208539", "2939827", "3015276088", "3010703925", "3027245002", "3036666444", "3005496266", "9616047", "3044744649", "9613445", "3003600763", "3026043045", "3008632256", "3004977335", "3039211310", "3031503890" ], "fei_number": [ "3003377038", "3002175190", "1000124212", "3010687441", "3019373577", "3008921184", "3008496839", "3023003446", "2183066", "3010208539", "1000646577", "3015276088", "3010703925", "3027245002", "3036666444", "3005496266", "3044744649", "3003600763", "3026043045", "3008632256", "3004977335", "3039211310", "3031503890" ], "device_name": "Densitometer, Bone", "medical_specialty_description": "Radiology", "regulation_number": "892.1170", "device_class": "2" } } ] }