{ "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": "203256", "product_res_number": "Z-0036-2024", "event_date_initiated": "2023-09-06", "event_date_posted": "2023-10-04", "recall_status": "Open, Classified", "res_event_number": "93005", "product_code": "FQO", "product_description": "Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment.\nModel Number: 7200.01F2", "code_info": "UDI Code: 04046768124363\n\nSerial Numbers:\n7\n10\n9\n18\n16\n14\n15\n17\n13\n24\n21\n22\n23\n20\n25\n19\n26\n32\n28\n29\n30\n31\n27\n42\n44\n45\n46\n47\n48\n49\n50\n51\n54\n59\n60\n52\n53\n56\n57\n63\n67\n74\n64\n68\n72\n73\n65\n69\n70\n71\n66\n75\n77\n78\n80\n81\n82\n79\n89\n83\n84\n85\n86\n87\n88\n90\n91\n93\n92\n94\n95\n96\n104\n105\n99\n101\n100\n102\n98\n106\n107\n108\n97\n103\n113\n111\n112\n114\n115\n119\n110\n116\n118\n125\n127\n128\n132\n129\n130\n131\n123\n124\n126\n138\n134\n135\n137\n139\n141\n142\n143\n140\n154\n146\n156\n145\n147\n149\n148\n150\n151\n155\n161\n165\n166\n164\n167\n169\n171\n170\n157\n162\n159\n158\n163\n168\n172\n174\n175\n178\n179\n176\n177\n152\n153\n180\n181\n183\n185\n182\n186\n193\n196\n188\n195\n189\n192\n194\n190\n502\n503\n504\n505\n506\n507\n510\n508\n509\n511\n512\n513\n514\n516\n520\n524\n523\n521\n527\n518\n519\n534\n535\n536\n532\n533\n541\n538\n539\n537\n540\n544\n545\n546\n547\n548\n549\n553\n550\n551\n554\n555\n557\n558\n556\n561\n563\n564\n565\n566\n569\n571\n572\n567\n573\n581\n579\n580\n583\n585\n586\n587\n584\n588\n589", "firm_fei_number": "3013876692", "recalling_firm": "Getinge Usa Sales Inc", "address_1": "1 Geoffrey Way", "city": "Wayne", "state": "NJ", "postal_code": "07470-2035", "reason_for_recall": "Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "Maquet GMBH / Getinge initiated Urgent Medical Device Correction letter on 9/6/23 via Fed'X. Letter states reason for recall, health risk and action to take:\nPlease examine your inventory immediately to determine if you have any of the Meera Mobile Operating Table with the serial numbers listed in this notice. Maintain awareness on this notice and related actions until your operating table has been updated to ensure effectiveness of the corrective action.\nPlease complete and sign the attached MEDICAL DEVICE 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 \nmeera-unintendedmovement2023.sw.qrc@getinge.com or by faxing the form to 800-746-3592\nPlease forward this information to all current and potential Meera Mobile Operating Table users within your hospital / facility.\nIf you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action.\n\nGetinge has developed a correction to address this issue. A Getinge Service representative will contact you to schedule the correction. This work will be done at no cost to your facility.\n\nIf you have any questions, please contact your Maquet\n/Getinge representative Getinge Technical Support at (888) 943-8872 (press option 4, then option 2, then option 1) Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).", "product_quantity": "224 units", "distribution_pattern": "US Nationwide distribution.", "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" } } ] }