{ "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": "204422", "product_res_number": "Z-0595-2024", "event_date_initiated": "2023-11-14", "event_date_posted": "2024-09-30", "recall_status": "Open, Classified", "res_event_number": "93462", "product_code": "DTQ", "k_numbers": [ "K133598" ], "product_description": "CARDIOHELP-i Heart Lung Support System: 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 (up to six hours).\nProduct REF Numbers:\n701072780; 701048012", "code_info": "UDI-DI:\n04058863074863; \n04037691658384\n\nAll serial numbers up to and including 90415172", "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": "CARDIOHELP-i System was not properly tested to measure leakage current", "root_cause_description": "Process design", "action": "Maquet Cardiopulmonary GmbH (MCP)/Getinge issued Urgent Medical Device Correction Letter to U.S, consignees November 14, 2023 via FedEx. Letter states reason for recall, health risk and action to take:\nPlease examine your inventory immediately to determine if you have any affected\nCARDIOHELP-i in your inventory.\n\" Whether or not your facility has affected product(s) listed in this notice, please 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 Getinge by e-mailing a scanned copy to Cardiopulmonary-cardiohelpleakage2023.cp@getinge.com or by faxing the form to 1-800-530-6084.\n\" If you report having any affected CARDIOHELP-i devices, a local Getinge representative will contact you to arrange a system check of the device to ensure that leakage current is within specifications.\n\" Affected CARDIOHELP-i devices are not requested to be returned and can be used as\nusual.\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.\nType of Action by Getinge:\nGetinge has identified the issue to be related to a supplier using an incorrect drawing to produce a tool used to measure leakage current of the CARDIOHELP-i. This issue has been corrected by the supplier.\nMCP/Getinge will contact you to arrange for a MCP/Getinge service technician to perform a system check of any affected device you report to confirm leakage current is within specifications (IEC 62353). If a system fails the performed test, the MCP/Getinge service technician will replace the system s sensor panel for you. MCP/Getinge service may have already performed the required system check of your device during a past preventative maintenance. MCP/Getinge will check service records to confirm. MCP", "product_quantity": "1594 units", "distribution_pattern": "Nationwide-WW Distribution to Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, French Polynesia, Germany, Ghana, Greece, Hong Kong, Iceland, India, Iran, Islamic Republic Of, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Macao, Maldives, Martinique, Mayotte, Mexico, Netherlands, New Zealand, Norway, Oman, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom,Vietnam, Yemen", "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" } } ] }