{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "217747", "product_res_number": "Z-1300-2026", "event_date_initiated": "2026-01-09", "event_date_posted": "2026-02-05", "recall_status": "Open, Classified", "res_event_number": "98159", "product_code": "DTQ", "k_numbers": [ "K133598" ], "product_description": "Bubble Sensor for 3/8\" x 3/32\" tubing;\nModel Number: 701055720;", "code_info": "Model Number: 701055720;\nUDI-DI: 04037691816432;\nSerial Numbers: All units impacted;", "firm_fei_number": "3009507273", "recalling_firm": "Maquet Cardiopulmonary Gmbh", "address_1": "Kehler Str. 31 31 kehler str.", "city": "Rastatt", "country": "Germany", "reason_for_recall": "Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.", "root_cause_description": "Under Investigation by firm", "action": "On or around January 9, 2026, \"URGENT MEDICAL DEVICE RECALL\" letters were sent to customers. Customers were instructed to take the following actions:\n- Please examine your inventory immediately to determine if you have any affected product in your inventory and utilize the recommended mitigations listed above until replacement sensors are available.\n- Complete and return the enclosed response form Getinge by e-mailing a copy to\nrecallresponses.qrc@getinge.com.\n- Contact Customer Service via email at ACTSalesSupport.US@Getinge.com or 888-943-8872, ext 28849 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to order a replacement sensor that will be shipped once available. Affected sensors will be returned to Getinge at time of replacement.\n- Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred.\n\nIf you have any questions, contact Customer Service via email at ACTSalesSupport.US@Getinge.com or 888-943-8872, ext 28849 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone).", "product_quantity": "3050 units", "distribution_pattern": "Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of (South Korea), Latvia, Lithuania, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, and Vietnam", "openfda": { "k_number": [ "K950990", "K964017", "K870976", "K091007", "K131041", "K221373", "K060053", "K021694", "K163531", "K232291", "K092463", "K103762", "K002116", "K822068", "K221895", "K942582", "K030141", "K871131", "K842138", "K190282", "K080832", "K770002", "K173834", "K153376", "K851614", "K172220", "K772001", "K851615", "K915183", "K052555", "K151349", "K133598", "K090006", "K062396", "K011088", "K102726", "K982014", "K861388", "K002118", "K801097", "K093882", "K943803", "K813034", "K022947", "K020571", "K070213", "K210130", "K862973", "K202125", "K863960", "K863541", "K071318" ], "registration_number": [ "3010163695", "3002807090", "1828100", "3011554160", "3042990265", "9680841", "8010762", "9611109", "3007427881", "3005941719", "3006073153", "3010703925", "2916596", "3009507273", "3001589655", "1218444", "3019807891", "2184009" ], "fei_number": [ "3010163695", "1828100", "3011554160", "3042990265", "3002807111", "3005426550", "3007427881", "3006073153", "3006003617", "3010703925", "2916596", "3009507273", "1000116158", "3009649876", "3002808267", "3001589655", "1218444", "3019807891" ], "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.4220", "device_class": "2" } } ] }