{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "183828", "product_res_number": "Z-0132-2021", "event_date_initiated": "2020-09-24", "event_date_created": "2020-10-20", "recall_status": "Terminated", "event_date_terminated": "2023-02-28", "res_event_number": "86495", "product_code": "FQO", "product_description": "Yuno Mobile Operating Table - Product Usage: Intended for support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.\nPart 143301F0 (US)\nPart 143301B0 (OUS)", "code_info": "Part 143301F0: SN 1 to SN 90  Part 143301B0: SN 1 to SN 267 (OUS)", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Cardiovascular Us Sales, Llc", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "SAME\n973-709-7000", "reason_for_recall": "Plastic socket of the IEC 60320-1 socket pulled out of the metal cage and electronic parts exposed; where the socket was pulled out and main cable is still connected to the main socket (power source), there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed electronic components", "root_cause_description": "Under Investigation by firm", "action": "Getinge issued Urgent Medical Device Recall on September 24, 2020, via FedEx 2 day delivery to US consignees. The letter states reason for recall, health risk and action to take: Per the IFU, section 9.1 (Yuno) and 8.1 (Yuno II), a visual and functional check is required to be performed by a trained person before operation.\nFollow the instructions in section 4.2.3.1of the Yuno and Yuno II IFU regarding connecting and disconnecting from the mains socket (power source).\nIf the plastic socket of the cold-device plug is pulled out, do not try to put it back into the housing and if there are any exposed electronic components, do not touch them. Disconnect/detach the cable from the main socket, call your in-house technical service and arrange the repair of the table. Per IFU section 9.4\n(Yuno) and 8.5 (Yuno II), a defective product may not be used and may not be repaired by yourself. A Getinge Service representative will contact\nyou to schedule the correction. This work will be done at no cost to your facility\n\nPlease complete and sign the attached URGENT MEDICAL DEVICE RECALL CORRECTION RESPONSE FORM (page 4) to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to MEERA2019@getinge.com or by faxing the form to 1-973-807-9205", "product_quantity": "62 units US", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of \nARGENTINA, AUSTRALIA, BAHRAIN, BOLIVIA, BRAZIL, \nBULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, FINLAND, FRANCE\nGERMANY, HONG KONG, HUNGARY, INDIA, INDONESIA, \nIRAQ, ISRAEL, ITALY, JAPAN, KENYA, KOREA, KUWAIT, \nLATVIA, LEBANON, MACAU, MACEDONIA, MALAYSIA, MEXICO, NEW ZEALAND, OMAN, POLAND, QATAR, \nROMANIA, RUSSIAN FEDERATION, RWANDA, SAUDI ARABIA, SERBIA, SINGAPORE, SOUTH AFRICA, SPAIN, \nSWEDEN, SWITZERLAND, TUNESIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.", "openfda": { "k_number": [ "K864295", "K924700", "K880227", "K972810", "K971988", "K926525", "K921143", "K936308", "K961742", "K921626", "K951854", "K831086", "K921297", "K090136", "K926463", "K940068", "K942043", "K941150", "K882660", "K932186", "K841115", "K961886", "K915141", "K971307", "K920890", "K864325", "K963506", "K953980", "K240598", "K930493", "K955750", "K950192", "K922371", "K221410", "K942486" ], "registration_number": [ "", "3008786200", "3005285078", "3012272052", "3013685983", "1033902", "9611500", "8010652", "2027467", "9610612", "3001104093", "1047843", "3040337865", "3032910452", "3026311463", "1000122786", "1643116", "3017181414", "3015223105", "3004137296", "3007682310", "3007591382", "3010373494", "3010373263", "3015978022", "3037012186", "1054713", "3007014520", "3002807616", "3043654660", "3044829820", "1043572", "3021839632", "2183744", "1066427", "3013522950", "3010037894", "3014739961", "2518443", "3006142326", "3031563141", "3035641086", "3003477135", "2936485", "2921578", "3003768277", "3031025858", "3003786160", "3006800085", "3017847344", "3003950207", "3012708860", "2221819", "2030380", "3019878714", "3007055152", "3006467297", "3023808059", "3010373530", "3010673832", "8021896", "3009028104", "3010326005", "3011580044", "3029970239", "3026790309", "3006105501", "3005698350", "3027847726", "9680168", "2031963", "3042471748", "3011910987", "3035111606", "1825014", "3007836437" ], "fei_number": [ "", "3008786200", "3005285078", "3012272052", "3013685983", "1033902", "2027467", "3001104093", "1047843", "3040337865", "3032910452", "3026311463", "1000122786", "1643116", "3017181414", "3015223105", "3004137296", "3007591382", "3007014520", "3010373494", "3007513035", "3010373263", "3015978022", "3037012186", "1000114111", "3002807616", "3043654660", "3023530182", "1043572", "2183744", "3044829820", "3013522950", "3010037894", "3014739961", "3001168737", "2518443", "3006142326", "3031563141", "3035641086", "3003477135", "2936485", "2921578", "3031025858", "3003786160", "3006800085", "3017847344", "3002975342", "3003950207", "3012708860", "2221819", "3019878714", "3007055152", "3002806315", "3006467297", "1000125341", "3002807880", "1000295034", "3023808059", "3010373530", "3010673832", "3009028104", "3010326005", "3011580044", "3029970239", "3026790309", "1000214453", "3006105501", "3005698350", "3027847726", "3042471748", "3011910987", "3035111606", "1841", "1825014", "3007836437", "1000519805" ], "device_name": "Table, Operating-Room, Ac-Powered", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4960", "device_class": "1" } } ] }