{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204353", "product_res_number": "Z-0555-2024", "event_date_initiated": "2023-11-06", "event_date_posted": "2023-12-14", "recall_status": "Open, Classified", "res_event_number": "93450", "product_code": "DTQ", "k_numbers": [ "K133598" ], "product_description": "CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass\nPart Number: \n701072780, (CARDIOHELP-I US);\n701048012 (CARDIOHELP-I NON US)", "code_info": "UDI Code:\n04058863074863 (CARDIOHELP-I US);\n04037691658384 (CARDIOHELP-I NONUS).\n\nAll serial numbers up to and including 90415177.", "firm_fei_number": "3008355164", "recalling_firm": "Maquet Medical Systems USA", "address_1": "45 Barbour Pond Dr", "city": "Wayne", "state": "NJ", "postal_code": "07470-2094", "additional_info_contact": "SAME\n973-709-7000", "reason_for_recall": "Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp", "root_cause_description": "Labeling design", "action": "Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device- Correction Customer Letter to US consignees issued on 11/6/23 via express mail. Letter states reason for recall, health risk and action to take:\n\nPlease examine your inventory immediately to determine if you have any affected\nCARDIOHELP-i in your inventory.\n\" Please review, download, and print the updated IFU for these products at:\nhttps://us.getinge.com/l/950532/2023-10-13/ppb1d2\n\" Please remove and destroy any previous versions of the IFU at your facility.\n\" As noted in the Key User Functions section of the IFU:\n\" Before beginning the application, ensure that the selected warning and alarm\nlimits, as well as interventions, are suitable and safe for the patient and the current\nsituation.\n\" Before beginning the application, check every intervention selected by simulating\nan alarm condition.\n\" Should you have any questions or need additional copies of the IFU, please contact Getinge Customer Support at (888) 943-8872 (select option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone).\n\" Please forward this information to all current and potential CARDIOHELP-i users within\nyour hospital / facility.\n\" If you are a distributor who has shipped any affected products to customers, please\nforward this document to their attention for appropriate action.\n\nWhether or not your facility has affected product(s) listed in this notice, please complete and\nsign the attached MEDICAL DEVICE - CORRECTION RESPONSE FORM (Page 5) to\nacknowledge that you have received this notification. Return the completed form to Getinge by\ne-mailing a scanned copy to CardiohelpIFU2023.qrc@getinge.com or by faxing the form to 1-\n800-861-0842.\nType of Action by Getinge:\nThe corrected IFU for the CARDIOHELP-i Heart Lung Support System is available at the web link included in this letter. Getinge will also send a hard copy of the IFU to those customers who request one.", "product_quantity": "1595 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Brazil, Brunei, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong,\nHungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Maldives, Martinique, Mauritius, Mayotte, Mexico, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Republic of Korea, R¿union, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam.", "openfda": { "k_number": [ "K842138", "K011088", "K052555", "K813034", "K863960", "K090006", "K822068", "K133598", "K021694", "K210130", "K861388", "K002116", "K071318", "K173834", "K943803", "K871131", "K221373", "K862973", "K851615", "K080832", "K870976", "K801097", "K915183", "K151349", "K060053", "K092463", "K190282", "K030141", "K070213", "K091007", "K020571", "K163531", "K772001", "K062396", "K103762", "K002118", "K863541", "K982014", "K102726", "K022947", "K942582", "K770002", "K232291", "K153376", "K221895", "K964017", "K202125", "K950990", "K172220", "K131041", "K851614", "K093882" ], "registration_number": [ "2916596", "9680841", "3007427881", "1828100", "3010163695", "3042990265", "2184009", "1218444", "8010762", "9611109", "3019807891", "3006073153", "3002807090", "3010703925", "3009507273", "3005941719", "3011554160", "3001589655" ], "fei_number": [ "2916596", "1000116158", "3007427881", "1828100", "3010163695", "3042990265", "1218444", "3002808267", "3019807891", "3006073153", "3010703925", "3009649876", "3006003617", "3002807111", "3009507273", "3011554160", "3001589655", "3005426550" ], "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4220", "device_class": "2" } } ] }