{ "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": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Eslov", "state": "", "country": "Sweden", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "67029", "recalling_firm": "Arjo Hospital Equipment AB", "address_1": "Verkstadsvagen 5", "address_2": "", "postal_code": "N/A", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution - US: Nationwide in the states of (AZ, CA, CO, CT, GA, ID, IL, MA, MD, MN, NC, NE, OH, PA, RI, SD, TX, VA, WI); and the countries of Australia, Austria, Bahrain, Belgium, Canada, Denmark, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Lebanon, Mexico, Netherlands, New Zealand, Norway, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, United Arab Emirates", "recall_number": "Z-0019-2015", "product_description": "ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.", "product_quantity": "1,695 beds (worldwide)", "reason_for_recall": "There is a low but existing entrapment risk for a patient being treated on the Contoura 1000 and Contoura 1080 bariatric beds if they have a BMI < 40.", "recall_initiation_date": "20140317", "center_classification_date": "20141006", "termination_date": "20180214", "report_date": "20141015", "code_info": "1) Model Number: C1000; Serial Numbers (Foreign): 62265 , 399945 , 399946 , 399949 , 416912 , 416914 , 423215 , 475309 , 530882 , 554079 , 554082 , 566463 , 584837 , 586554 , 592203 , 592204 , 592205 , 592206 , 597027 , 597028 , 605859 , 646152 , 664632 , 680670 , 680699 , 693924 , 695671 , 699563 , 712231 , 714227 , 714228 , 714229 , 716809 , 720277 , 725622 , 731631 , 745781 , 745782 , 747354 , 747355 , 748161 , 748162 , 748635 , 761635 , 766430 , 766430 , 766431 , 766431 , 771194 , 771195 , 771197 , 771198 , 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P070713 , P070770 , P071349 , P071350 , P071451 , P073778 , P073847 , P073934 , P075170 , P076716 , P076719 , P076849 , P076950 , P078419 , P079322 , P079323 , P080384 , P083938 , P084481 , P084594 , P085062 , P086507 , P086508 , P086830 , P086831 , P087584¿¿¿¿ , P087585 , P087853 , P088197 , P088210 , P088272 , P088570 , P088655 , P092355 , P093705 , P093834 , P094960 , P094961 , P096673 , P096674 , P096675 , P097132 , P097311 , P097500 , P099166 , P099167 , P099444 , P099445 , P099721 , P100052 , P100053 , PO106703 , PO106704 , PO106706 , PO29057 , PO29058 , PO29059 , PO84691 , PO84692 , PO84693 , PO84694 , PO84695 , PO84696 , PO84697 , PO84698 ; 1) Model Number C1080; Serial Numbers (US): 416930 , 766425 , 473239 , 773201 , 851902 , 416917 , 491904 , 545574 , 473246 , 416932 , 473245 , 473238 , 82730 , 783942 , 416919 , 473243 , 545569 , 473234 , 416920 , 416926 , 473236 , 830902 , 416927 , 491906 , 416931 , 416921 , 491895 , 745779 , 561704 , 561689 , 766423 , 416922 , 774737 , 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P079075 , P079321 , P081497 , P081583 , P081584 , P081854 , P082674 , P083243 , P083666 , P084374 , P086826 , P087950 , P088488 , P094207 , P094411 , P096286 , P097604 , P0M6050 , PO137838 , PO146396 , PO190805 , PO19275 , PO47568 , R61213", "more_code_info": "" } ] }