{ "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": "195311", "product_res_number": "Z-1568-2022", "event_date_initiated": "2022-07-21", "event_date_created": "2022-08-24", "recall_status": "Open, Classified", "res_event_number": "90648", "product_code": "CBK", "k_numbers": [ "K192604" ], "product_description": "Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients.\nModel Number: \t6882000 (equipped with 6881999 mobile cart)", "code_info": "UDI-DI: 07325710003114\n\nSerial Numbers:\n10558\n12349\n20122\n20135\n20148\n21704\n23177\n23169\n23430\n23652\n23749\n23762\n10561\n12350\n20123\n20136\n20150\n21705\n23178\n23171\n23431\n23653\n23750\n23763\n10567\n12351\n20124\n20137\n20151\n21706\n23179\n23188\n23432\n23654\n23751\n23857\n10569\n12352\n20125\n20138\n20153\n21707\n23180\n23375\n23429\n23655\n23752\n23858\n10573\n12353\n20126\n20139\n20155\n22206\n23183\n23376\n23536\n23656\n23753\n23973\n10575\n12354\n20127\n20140\n20149\n22551\n23185\n23377\n23537\n23657\n23754\n23974\n10579\n12355\n20128\n20141\n20152\n22552\n23187\n23422\n23538\n23658\n23755\n23975\n10580\n20117\n20129\n20142\n20156\n22865\n23294\n23423\n23539\n23659\n23756\n24013\n10585\n20116\n20130\n20143\n20157\n23181\n23164\n23424\n23563\n23660\n23757\n24014\n10586\n20118\n20131\n20144\n20300\n23176\n23165\n23425\n23551\n23661\n23758\n24015\n12287\n20119\n20132\n20145\n20529\n23184\n23166\n23426\n23552\n23697\n23759\n24016\n12347\n20120\n20133\n20146\n21702\n23128\n23167\n23427\n23650\n23698\n23760\n24017\n12348\n20121\n20134\n20147\n21703\n23175\n23168\n23428\n23651\n23699\n23761", "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": "Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be permanently marked with a clearly legible warning of this risk", "root_cause_description": "Device Design", "action": "Maquet Critical Care AB/Getinge issued Urgent Medical Device Correction letter to US consignees on 7/21/22 for delivery on Monday, July 25th via FedEX.\nIf you have a Servo-air Ventilator System with one or more of the serial numbers listed on page 1 of this notification, a Getinge trained or authorized service technician will affix Symbol, ISO 7010:P019 \"Do not step\", (according to IEC 60601-1) to your Servo-air Ventilator system. \nLetter states reason for recall, health risk and action to take:\n1.\tPlease examine your inventory immediately to determine if you have received any Servo-air Ventilator devices with one of the affected serial numbers.\n\n2.\tIf you have a Servo-air Ventilator device affected by this field correction, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 6). Your affected device/(s) will be corrected during your next planned maintenance or other service visit.\n\nHowever, if you do not maintain a service contract with Getinge, you may contact Getinge to arrange a visit by a Getinge trained or authorized service technician by contacting Getinge Tech Support at (888) 9GETUSA / (888) 943-8872 (select option 4, then option 2), between the hours of 8:00 a.m. and 6:00 p.m. Eastern Standard Time.\nThis correction will be performed at no cost to your facility.\n\n3.\tPlease return the completed form to Getinge by emailing a scanned copy to Servoair2022.us@getinge.com or by faxing the form to 1(973) 860-2462.\n\n4.\tWhether or not you have affected product(s) with the serial numbers listed in this notice, please complete and sign the attached MEDICAL DEVICE CORRECTION - RESPONSE FORM (page 6) to acknowledge that you have received this notification, per the instruction in number 3 above.\n\n5.\tPlease forward this information to all current and potential Servo-air Ventilator System users within your hospital/facility.\n\n6.\tIf you are a distributor who has shipped any affected products to customers, please forward this document to t", "product_quantity": "US 102 units; OUS 13750 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia (AU), Brazil (BR), China (CN), Egypt (EG), EEA, Hong Kong (HK), Israel (IL), Japan (JP), Mexico (MX), Pakistan (PK), Saudi Arabia (SA), South Africa (ZA), South Korea (KR), Switzerland (CH), Taiwan (TW), Turkey (TR), and United Arab Emirates (AE).", "openfda": { "k_number": [ "K781926", "K884521", "K061627", "K941309", "K081743", "K102054", "K800114", "K864129", "K955865", "K923992", "K841529", "K083688", "K942938", "K884832", "K844081", "K822888", "K222024", "K100753", "K800125", "K252663", "K841279", "K030341", "K960168", "K010793", "K181695", "K232836", "K833982", "K092264", "K872113", "K984379", "K061090", "K241943", "K181216", "K032226", 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