{ "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": "204929", "product_res_number": "Z-0728-2024", "event_date_initiated": "2023-12-05", "event_date_posted": "2024-01-13", "recall_status": "Open, Classified", "res_event_number": "93595", "product_code": "LGX", "product_description": "Ultrasound EA (Ergonomic Advantage) table versions; G3 (General 3 Section) Echocardiography -An Ultrasound examination table", "code_info": "(UDI): , 00817463025439\nS/N: \nUSW821950\nUSW821951\nUSM838906\nUSM838908\nUSM838909\nUSM838910\nUSM838911\nUSM838912\nUSW833604\nUSW803220\nUSW810646\nUSM802363\nUSM802364\nUSM802365\nUSM802366\nUSM802367\nUSM802368\nUSM802369\nUSM802370\nUSM802371\nUSM802372\nUSM802373\nUSM806418\nUSM806419\nUSM824495\nUSW824575\nUSW824576\nUSW835742\nUSW835743\nUSW835744\nUSW835745\nUSW835870\nUSW835871\nUSW805335\nUSW805500\nUSW814481\nUSW814489\nUSW814490\nUSW814491\nUSM818829\nUSM818830\nUSW834435\nUSW834436\nUSW834437\nUSW834438\nUSW837136\nUSW837137\nUSW837138\nUSW837139\nUSW837140\nUSM834172\nUSW825108\nUSW836285\nUSW825254\nUSW825255\nUSW825256\nUSM832158\nUSM837032\nUSM805639\nUSM805640\nUSW809784\nUSW809785\nUSW810360\nUSM810619\nUSW811819\nUSW825625\nUSW825626\nUSW833747\nUSW806381\nUSW809243\nUSW810505\nUSM814053\nUSM814054\nUSM814055\nUSW829084\nUSW838113\nUSW838114\nUSW807763\nUSW800305\nUSM812019\nUSM812024\nUSM820560\nUSW832338\nUSM827491\nUSM805539\nUSM813172\nUSM813173\nUSM806277\nUSW817676\nUSW817677\nUSW818075\nUSW829140\nUSM809220\nUSM809200\nUSM809202\nUSM797137\nUSM819374\nUSM819375\nUSM819376\nUSM819377\nUSM819378\nUSM819379\nUSM819381\nUSM819382", "firm_fei_number": "1000121370", "recalling_firm": "Oakworks Inc", "address_1": "923 E Wellspring Rd", "city": "New Freedom", "state": "PA", "postal_code": "17349-8408", "additional_info_contact": "Stephen McKinley \n717-235-6807", "reason_for_recall": "Backrest platform stress fracture - the table is not operational in an inclined position", "root_cause_description": "Device Design", "action": "Oakworks Inc. issued \"URGENT: MEDICAL DEVICE RECALL/CORRECTION\" letter on 12/5/23 via Certified Mail/Email to Distributors and End Users. Letter states reason for recall, health risk and action to take:\n1.\tImmediately examine your inventory of OAKWORKS Inc. Ultrasound EA Table with Echocardiography, or Electric Access Back Supports [left & right] to identify and locate all affected product(s). \n\n2.\tFor tables in use, they remain fully functional if the backrest platform stress fracture has not occurred. For tables that have the stress fracture or break, only use in a flat position until the backrest is replaced. \n\n3.\tImplement the field action as described below for the product listed in the Product and Distribution Information Table.\n\n4.\tEnclosed is a Medical Device Advisory Notice Response Form for each product we believe you have. Please complete this form in its entirety and return to OAKWORKS Inc., within 48 hours of receipt of this advisory notice via any of the options listed below.\nMAIL: Oakworks Inc.\t \t\tEMAIL: customerservice@oakworks.com\nAttn: Customer Service MDAN Response\t\n 923 East Wellspring Rd.\t\t\t\t\n New Freedom, PA 17349\n\nAction by OAKWORKS Inc.:\nUpon receipt of the Medical Device Advisory Notice Response Form(s), and to minimize the downtime of your OAKWORKS Ultrasound EA table, we will setup a service visit to replace the backrest (if a stress fracture has occurred) or install a reinforcement plate (if a stress fracture has not occurred) on the table(s). The correction installation takes approximately 30 minutes. The replaced backrest will be disposed of by the service provider.\n\nAdditional Information:\nIf you have any questions or concerns, please contact our Customer Service Department at 800-558-8850 or 717-235-6807 Monday through Friday, 8:00 AM to 5:00 PM, Eastern Time.", "product_quantity": "104 units", "distribution_pattern": "US Nationwide Distribution", "openfda": { "device_name": "Table, Examination, Medical, Powered", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1", "k_number": [ "K832768", "K810900", "K882010", "K883680", "K860519", "K845023", "K864072", "K945163", "K820823", "K811623", "K811190", "K894144", "K830294", "K894134" ], "registration_number": [ "3007031002", "2916273", "3009715914", "1932056", "3003881889", "1225072", "3012494290", "2182536", "3006142326", "1000122786", "9681454", "3004905643", "3003548115", "9680168", "3008881803", "3043654660", "3009591865", "3006210673", "3003696170", "9613918", "3030488262", "3011719874", "3045978136", "3017181414", "3004976058", "3008533516", "3015978022", "3016245408", "1066427", "3012240979", "3005545844", "8023021", "3005065295", "3004137296", "3003102481", "3023805", "3004414785", "3043625036", "3007369190", "3010605276", "3008386649", "1648279", "3028240331", "2529571", "3005920099", "3003851947", "3008960494", "3010509576" ], "fei_number": [ "3007031002", "2916273", "3007513035", "3009715914", "3003881889", "3012494290", "2182536", "1000295034", "3006142326", "6423", "1000122786", "1000121370", "1000118382", "3004905643", "3002572935", "3003548115", "1000516389", "3008881803", "3043654660", "3009591865", "3006210673", "3003696170", "3030488262", "3011719874", "3045978136", "3017181414", "3004976058", "3000205157", "3008533516", "3015978022", "3016245408", "3005545844", "3012240979", "3004446977", "3005065295", "3004137296", "3003102481", "3023805", "3004414785", "3043625036", "3007369190", "3010605276", "3008386649", "3028240331", "3005920099", "3003851947", "3008960494", "3010509576" ] } } ] }