{ "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": "216680", "product_res_number": "Z-0436-2026", "event_date_initiated": "2025-10-09", "event_date_posted": "2025-11-06", "recall_status": "Open, Classified", "res_event_number": "97830", "product_code": "IYN", "k_numbers": [ "K231764" ], "product_description": "Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic", "code_info": "1) 1300-21: GTIN 05704916001285 and pending, Serial Numbers: 2002690, 2008466, 2008495, 2006774, 5012683, 5013881, 5012684, 2008725, 2008280, 2004419, 5012980, 2007101, 2009029, 5014333, 2003852, 2002851, 2002142, 2005860, 5013937, 2007188, 2002950, 2003495, 2008470, 5013934, 5013935, 5016211, 2005193, 5014141, 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2004635, 2004637, 2004785, 2004796, 2004797, 2004931, 2004946, 2004952, 5015874.", "firm_fei_number": "3003705156", "recalling_firm": "B-K Medical A/S", "address_1": "Mileparken 34 34 mileparken", "city": "Herlev", "country": "Denmark", "additional_info_contact": "BK Medical Service\n800-6454222", "reason_for_recall": "GE HealthCare has become aware that the Instructions for Use within the user guide and service manual do not adequately state the required battery replacement intervals, end-of-life handling procedures, or general battery safety precautions.", "root_cause_description": "Device Design", "action": "GE Healthcare issued an \"URGENT MEDICAL DEVICE CORRECTION NOTICE\" to its consignees on 10/09/2025 via traceable means. The notice explained the issue, potential risk, and requested: \n\"Actions to be taken by Customer / User \nYou can continue to use your device by following the instructions below:\n1. Review and follow the applicable addendums to the Instructions for Use and the updated Service Manuals. The Addendums and Service Manuals are available for download at: https://www.gehealthcare.com/support/manuals. \n2. Follow the conditions defined within the addendum and Service Manual applicable to your product for further instructions. \n3. Place the applicable addendum and Service Manual with your existing product Instructions for Use. \n4. If you have difficulty accessing the documentation or require a printed copy of the applicable addendum or Service Manual, please contact a GE HealthCare Service Representative for assistance. \n\nPlease ensure all potential users in your facility are made aware of this safety notification and the required actions. \n\nPlease retain this document for your records.\" \nFor questions or concerns regarding this notification, please contact GE HealthCare at 1-800-645-4442 or bksupport.us@gehealthcare.com or your local Service Representative.", "product_quantity": "1697 units", "distribution_pattern": "Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Rep, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Korea (Republic Of), Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Morocco, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkiye, Ukraine, United Arab Emirates, and United Kingdom.", "openfda": { "k_number": [ "K152309", "K891238", "K062247", "K141261", "K152195", "K180374", "K152165", "K162187", "K840953", "K103649", "K040596", "K253716", "K133431", "K181637", "K001711", "K090229", "K052042", "K172129", "K162549", "K123610", "K150002", "K073408", "K112122", "K242223", "K143089", "K171048", "K253597", "K802254", "K130801", "K173957", "K173486", "K251985", "K101312", "K200708", "K101878", "K153421", "K091009", "K010631", "K053084", "K813544", "K033139", "K200449", "K160807", "K241201", "K113690", "K211746", "K992663", "K152543", "K233195", "K840402", "K222198", "K872817", "K842055", "K002470", "K251192", 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