{ "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": 1 } }, "results": [ { "cfres_id": "185942", "product_res_number": "Z-1296-2021", "event_date_initiated": "2021-02-11", "event_date_created": "2021-03-23", "recall_status": "Open, Classified", "res_event_number": "87386", "product_code": "FQO", "product_description": "Operating Table System", "code_info": "Part Number: 118001A0, 118001B0, 118001B1, 118001B2, 118001B3, 118001B4, 118001C0, 118001D0. UDI code: 04046768031500, 04046768031531, 04046768040700, 04046768088351, 04046768088061, 04046768124752, 04046768031555, 04046768031579. Serial Number: 1 3402, 1 1028, 1 1264, 1 401, 3 74, 1 81, 2 1159, 2 - 762.", "firm_fei_number": "3025504317", "recalling_firm": "Getinge Group Logistics America, LLC", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "Allison Jean Kaplan\n973-709-7779", "reason_for_recall": "There is a potential for hydraulic leakage at the inclination function to occur resulting in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning which may lead to the patient having to be transferred to another OR table causing a delay in the procedure.", "root_cause_description": "Device Design", "action": "In February, 2021, Maquet GmbH/Getinge, will issue an Urgent Medical Device Correction notice to customers via FedEx 2 Day Delivery for the Magnus 1180 Operating Table due to a potential for hydraulic leakage to occur at the inclination function which may result in an unintended Trendelenburg or anti-Trendelenburg movement of the table top depending on patient positioning. If this were to occur, it may lead to the patient having to be transferred to another OR table causing a delay in the procedure.", "product_quantity": "4288 units", "distribution_pattern": "Domestic: AK, AL, AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. Foreign: Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Liechtenstein, Lithuania, Luxembourg, Lybia, Macedonia, Malaysia, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Caledonia, New Zealand, Norway, Oman, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom, Uzbekistan, Venezuela, Vietnam and Yemen.", "openfda": { "k_number": [ "K882660", "K221410", "K831086", "K950192", "K841115", "K951854", "K924700", "K942043", "K864295", "K971307", "K930493", "K936308", "K922371", "K920890", "K926525", "K932186", "K972810", "K880227", "K915141", "K961886", "K940068", "K942486", "K090136", "K864325", "K963506", "K926463", "K955750", "K921143", "K240598", "K941150", "K921626", "K961742", "K953980", "K921297", "K971988" ], "registration_number": [ "", "3004137296", "3031025858", "2936485", "3026311463", "3029970239", "9611500", "3031563141", "2221819", "3015223105", "3010326005", "3007014520", "3010037894", "3012272052", "1043572", "8010652", "3040337865", "1033902", "9680168", "3026790309", "3013685983", "3007591382", "3032910452", "2518443", "3044829820", "3042471748", "3021839632", "1643116", "3003950207", "3015978022", "3023808059", "2030380", "3007836437", "3019878714", "2183744", "3003477135", "3010373494", "3017847344", "3008786200", "1047843", "3011910987", "3007055152", "3006467297", "8021896", "3005285078", "3043654660", "3013522950", "3009028104", "3015179588", "3027847726", "3006142326", "9610612", "3006105501", "2921578", "3037012186", "3035641086", "2027467", "3014739961", "1825014", "3012708860", "3017181414", "3007682310", "3003768277", "3010673832", "3002807616", "1000122786", "3035111606", "3003786160", "3006800085", "3005698350", "3001104093", "1054713", "1066427", "3010373530", "3011580044", "2031963", "3010373263" ], "fei_number": [ "", "3004137296", "3031025858", "3023530182", "3001168737", "2936485", "3026311463", "3029970239", "3031563141", "2221819", "3015223105", "3010326005", "3007014520", "3010037894", "3012272052", "1043572", "3007513035", "3040337865", "1033902", "3026790309", "3013685983", "3007591382", "3032910452", "2518443", "3044829820", "3042471748", "1643116", "3003950207", "3015978022", "3023808059", "3007836437", "3019878714", "1000125341", "2183744", "3003477135", "3010373494", "3017847344", "3008786200", "3002975342", "1047843", "3011910987", "1000114111", "3007055152", "3006467297", "3005285078", "3043654660", "1000214453", "3013522950", "3009028104", "3015179588", "3027847726", "3006142326", "3006105501", "2921578", "3037012186", "1000519805", "3002807880", "3035641086", "2027467", "3014739961", "1825014", "3012708860", "3017181414", "3010673832", "1000295034", "3002807616", "1000122786", "3035111606", "3003786160", "3006800085", "3005698350", "3002806315", "3001104093", "3010373530", "3011580044", "3010373263", "1841" ], "device_name": "Table, Operating-Room, Ac-Powered", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1" } } ] }