{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "219088", "product_res_number": "Z-2167-2026", "event_date_initiated": "2026-04-08", "event_date_posted": "2026-05-12", "recall_status": "Open, Classified", "res_event_number": "98566", "product_code": "MUE", "pma_numbers": [ "P010025" ], "product_description": "SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS. Model Numbers: SDA-SYS-3000-2D-HTC, SDA-SYS-3000-3D, SDM-SYS-6000-2D, SDM-SYS-6000-3D, SDM-00001-2D, SDM-00001-3D, SDM-00001-M2D, SDM-00001-M3D, SDM-05000-2A2, SDM-05000-2A3, SDM-05000-2AC, SDM-05000-2D2, SDM-05000-2D3, SDM-05000-2DC, SDM-05000-3D2, SDM-05000-3D3, SDM-05000-3DC, SDM-SYS-9000-2D, SDM-SYS-9000-3D.", "code_info": "\"Model No.; UDI\": [SDA-SYS-3000-2D-HTC;15420045510616], [SDA-SYS-3000-3D;15420045517783], [SDM-SYS-6000-2D;15420045510753], [SDM-SYS-6000-3D;15420045510760], [SDM-00001-2D;15420045510623], [SDM-00001-3D;15420045510630], [SDM-00001-M2D;15420045510647], [SDM-00001-M3D;15420045510654], [SDM-05000-2A2;15420045510661], [SDM-05000-2A3;15420045510678], [SDM-05000-2AC;15420045510685], [SDM-05000-2D2;15420045510692], [SDM-05000-2D3;15420045510708], [SDM-05000-2DC;15420045510715], [SDM-05000-3D2;15420045510722], [SDM-05000-3D3;15420045510739], [SDM-05000-3DC;15420045510746], [SDM-SYS-9000-2D;15420045510777], [SDM-SYS-9000-3D;15420045510784]; All Serial No.", "firm_fei_number": "1000120743", "recalling_firm": "Hologic, Inc", "address_1": "250 Campus Dr", "city": "Marlborough", "state": "MA", "postal_code": "01752-3020", "additional_info_contact": "Breast Health Customer Support\n+1-800-4429892", "reason_for_recall": "Complaints have been received of systems developing loose, missing, or broken internal bolts over time.", "root_cause_description": "Device Design", "action": "On April 8, 2026 URGENT FIELD SAFETY NOTICE letters were sent to customers. Customers were informed of implementing an updated recurring maintenance inspection for detecting loosened, missing, or broken bolts within the VTA. Hologic Service will reach out to schedule your service appointment and perform the required inspection. Following the initial inspection, recurring inspections are required to be conducted at least every 6 months to ensure continued safe/proper operation of the system. Future inspections will consist of torque and visual confirmation that all bolts are present and that there is no indication of loosening.\nActions: \nYou may continue to use your 3Dimensions or Selenia Dimensions for its intended use. If at any time during system operation, you observe unexpected C-Arm movement, please discontinue use and contact Hologic s Technical Support immediately.\nReport suspected device complaints and/or adverse events to Hologic and the FDA (contact details below).\nAfter initial inspection by Hologic, it is required to have the inspection performed at least every 6 months as well as the other defined maintenance and service activities which are critical for continued safe and effective operation of the Selenia Dimensions or 3Dimensions system.\nForward this notice to anyone in your facility that needs to be informed.\nPost a copy of this notice in a visible area near the affected devices where operators can view for awareness and please keep a copy for your records.", "product_quantity": "4,305 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K170930", "K122510", "K172027", "K243849", "K163328", "K193334", "K211720", "K241113", "K162670", "K243420", "K111361", "K110729", "K123520", "K110572", "K120246", "K121674", "K182951", "K163302", "K103485", "K212873", "K173576", "K211725", "K220073", "K254092", "K253678", "K211215", "K202822", "K122286", "K210151", "K121963", "K193166", "K200424", "K120255", "K110717", "K172404", "K162268", "K130704", "K202902", "K151645", "K111324", "K163252", "K190809", "K110798", "K110025", "K173132", "K131885", "K111646", "K233539", "K133972", "K173408", "K111434", "K260087", "K123873", "K123995", "K192317" ], "pma_number": [ "P030010", "P010017", "P990066", "P010025", "P050014", "P080018" ], "registration_number": [ "3001722928", "3005877899", "3004977335", "3009196578", "3003769120", "3008833258", "9613152", "3023003446", "3017585294", "3027339477", "3008496839", "3000126629", "3012127758", "3005172103", "3009048384", "3009868110", "3015276088", "3003768251", "3009717300", "3025442726", "3010703925", "3004485675", "3005843418", "3003775006", "1423253", "9611343", "3005810333", "3005496266", "8043728", "3005406110", "2433615", "3001556265", "3008355361", "3031503890", "1317307", "3010398867", "3017375271", "3008787461", "3021059265", "3006013411", "3035950510", "9680027" ], "fei_number": [ "3001722928", "3005877899", "3004977335", "3009196578", "3003769120", "3008833258", "3023003446", "1000284313", "3017585294", "3008496839", "3027339477", "3002807317", "3000126629", "3012127758", "3005172103", "3002807903", "3009048384", "3009868110", "3015276088", "3003768251", "3009717300", "3003772616", "3025442726", "3010703925", "3004485675", "3005843418", "3003775006", "3005810333", "3005496266", "1000514697", "3005406110", "2433615", "3001556265", "3008355361", "3031503890", "1317307", "3010398867", "3017375271", "3008787461", "3021059265", "3006013411", "3035950510" ], "device_name": "Full Field Digital, System, X-Ray, Mammographic", "medical_specialty_description": "Radiology", "regulation_number": "892.1715", "device_class": "2" } } ] }