{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214741", "product_res_number": "Z-2204-2025", "event_date_initiated": "2025-06-30", "event_date_posted": "2025-07-30", "recall_status": "Open, Classified", "res_event_number": "97172", "product_code": "LNH", "k_numbers": [ "K193215", "K213583" ], "product_description": "Ingenia 1.5T\nModel Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;", "code_info": "Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;\nUDI-DI: (1) 00884838099715, (2) 00884838055322, (3) 00884838009820, (4) 00884838098275, (5) 00884838099043, (6) 00884838108646;\nSerial Numbers: (1) 61000, 61001, 61002, 61003, 61004, 61005, 61006, 61007, 61008, 61009, 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61280, 61281, 61282, 61283, 61284, 61285, 61286, 61287, 61288, 61289, 61290, 61291, 61292, 61293, 61294, 61295, 61298, 61299, 61300, 61302, 61303, 61304, 61306, 61310, 61311, 61312, 61313, 61314, 61315, 61316, 61317, 61319, 61320, 61321, 61326, 61327, 61328, 61329, 61330, 61331, 61332, 61333, 61334, 61336, 61337, 61338, 61339, 61341, 61342, 61348, 61349, 61350, 61351, 61352, 61354, 61355, 61356, 61357, 61358, 61359, 61360, 61361, 61362, 61363, 61364, 61365, 61366, 61367, 61368, 61369, 61370, 61371, 61372, 61373, 61374, 61375, 61376, 61377, 61378, 61380, 61381, 61382, 61383, 61384, 61385, 61386, 61387, 61388, 61390, 61393, 61394, 61395, 61396, 61397, 61398, 61399, 61400, 61401, 61402, 61403, 61404, 61406, 61407, 61408, 61409, 61410, 61411, 61412, 61413, 61415, 61416, 61417, 61418, 61419, 61420, 61421, 61422, 61425, 61426, 61427, 61428, 61430, (6) 45601, 45602, 45606, 45607, 45608, 45609;", "firm_fei_number": "3006648320", "recalling_firm": "Philips North America", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2296", "additional_info_contact": "Customer Care Solution Center\n1-800-722-9377", "reason_for_recall": "The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.", "root_cause_description": "Device Design", "action": "On June 30, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. \n4. Actions that should be taken by the customer / user in order to prevent risks for patients or users\n4.1. When using any affected system identified according to the information in section 3, follow\nthe instructions below.\n4.2. Pay particular attention if a scan interruption occurs and a scan abort symbol is\nencountered, which may appear in the user interface (UI) with the symbols shown in Figure 4\nbelow:\nFigure 4. Scan Abort Symbols\n4.3. When scan aborts occur the symbol is shown and applicable messages are presented in the\nmessage box (see Figure 5 and Figure 6 examples)\n4.3.1. Check the status of the error messages in the User Interface (UI) screen. Click to\nexpand the message box in case previous messages are hidden, see orange box in\nFigure 5 and Figure 6 below. If possible, correct the issue that is relevant to the error\nshown and continue scanning, for example:\n RF door must be closed while performing scan. Scan aborted. \n Patient support is moved while scanning, scan stopped. \n Coil A (or B) failure, coil disconnected? .\n4.3.2. If, after a scan abort, one of the following conditions occur five times in a row stop\nscanning immediately and contact Philips Service to describe the problem:\n If there is no error message in the message box\n If the error message meaning is not clear\n4.3.3. If the error message Gradient amplifier Rack Fault is received two times in a row,\nor if the error message Gradient amplifier Rack Fault is preceded or followed by an\naborted scan with no message, then stop scanning immediately and contact Philips\nService to describe the problem.\n4.3.4. If you encounter any of these conditions described in 4.3.2 or 4.3.3 do not attempt\nany additional/further scans, including without limitation do not attempt any\nphantom scanning until your system has been checked and released by a Philips\nService representative.\n4.4. If smoke and/or fire is detected", "product_quantity": "2,279 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Belize, Bolivia, Bosnia-Herz., Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, El Salvador, Estonia, Fiji, Finland, France, French Guiana, FrenchPolynesia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Lesotho, Libya, Lithuania, Luxembourg, Macao, Macedonia, Madagascar, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Trinidad,Tobago, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Utd.Arab.Emir., Uzbekistan, Venezuela, Vietnam, Yemen, Zambia.", "openfda": { "k_number": [ "K232346", "K883520", "K250443", "K932344", "K121650", "K920441", "K102344", "K213583", "K240157", "K923823", "K081028", "K212367", "K100164", "K914536", "K924472", "K072998", "K240540", "K223426", "K903754", "K905512", "K160618", "K210415", "K173409", "K935084", "K962677", "K954646", "K033504", "K241496", "K895328", "K080968", "K193200", "K905095", "K211406", "K940364", "K233733", "K962618", "K221619", "K990550", "K230972", "K910513", "K982761", "K180925", "K920096", "K945828", "K944070", "K142734", "K973658", "K961969", "K031230", "K921941", "K142515", 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