{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197684", "product_res_number": "Z-1144-2023", "event_date_initiated": "2023-01-16", "event_date_posted": "2023-02-21", "recall_status": "Open, Classified", "res_event_number": "91415", "product_code": "OTE", "pma_numbers": [ "P080003" ], "product_description": "Hologic 3Dimensions/Selenia Dimensions \nModels:\nRM-SDM-00001-3D\nSDM-00001-2D\nSDM-00001-3D\nSDM-05000-3D3\nSDM-05000-2DC\nSDM-00001-M3D\nSDM-05000-3DC\nSDM-SYS-6000-3D\nSDM-05000-2D3\nSDA-SYS-3000-2D\nSDM-00001\nSDM-SYS-9000-2D\nSDM-00001-M2D\n3DM-SYS-STD\n3DM-SYS-STD-NS\nSDM-05000-2AC\nSDM-05000-2A2\nSDA-SYS-3000-3D\nSDA-SYS-3000-3D-UPS\nSDM-SYS-6000-3D-HTC\nSDM-05000-2D2\nSDM-05000-3D2\nSDM-SYS-6000-2D\nSDM-SYS-9000-3D", "code_info": "UDI: 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"firm_fei_number": "1220984", "recalling_firm": "Hologic, Inc.", "address_1": "36 Apple Ridge Rd", "city": "Danbury", "state": "CT", "postal_code": "06810-7301", "additional_info_contact": "Customer Support\n800-442-9892 Ext. 2", "reason_for_recall": "C-Arm unexpected movement may cause blunt trauma should the tube arm impinge upon an individual", "root_cause_description": "Device Design", "action": "Hologic issued Urgent Medical Device Correction Letter customized to the customer on 01/16/23. Letter states reason for recall, health risk and action to take:\nWe will schedule a service appointment and dispatch a field service engineer to visit your site to inspect your system and if necessary, make any corrections.\n\" This will take approximately 6-14 hours to complete.\n\" Until your service appointment, you will be able to continue to use your Selenia Dimensions or 3Dimensions system.\nIf at any time during system operation, you observe any unanticipated error messages, or unexpected Carm movement, please discontinue use and contact Hologic's Technical Support immediately.\nAdditionally, if you have any questions, please do not hesitate to reach out to Hologic's Technical Support at 1-877-371-4372 or breasthealth.support@hologic.com.\nComplete the on line Customer Confirmation Form using the link below within 3 business days of receiving this notice. Replying promptly will confirm your receipt of the notification and prevent you from receiving repeat notices.\nwww.novasyte.com/hologic/selenia-dimensions-2022", "product_quantity": "797 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "pma_number": [ "P080003", "P160031", "P140011", "P130020" ], "registration_number": [ "3015276088", "3005810333", "3036666444", "3012127758", "3040678329", "3012939903", "1423253", "3005496266", "3004977335", "3009196578", "3003775006", "3010703925", "3027339477", "3029521953", "3023003446", "3008833258", "3013875850", "3005877899", "3031503890", "3008496839", "9611343", "3001722928", "3019373577" ], "fei_number": [ "3015276088", "3005810333", "3036666444", "3012127758", "3040678329", "3012939903", "3005496266", "3004977335", "3009196578", "3003775006", "3010703925", "3027339477", "3029521953", "3023003446", "3008833258", "1000284313", "3013875850", "3005877899", "1000514697", "3031503890", "3008496839", "3001722928", "3019373577" ], "device_name": "Digital Breast Tomosynthesis", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }