{ "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": "204182", "product_res_number": "Z-0389-2024", "event_date_initiated": "2023-10-23", "event_date_posted": "2023-11-21", "recall_status": "Open, Classified", "res_event_number": "93361", "product_code": "LNH", "k_numbers": [ "K052013", "K052078", "K063559", "K162931", "K173079" ], "product_description": "Achieva 1.5T", "code_info": "Product No. 781178, 781196, 781296, & 781343; UDI-DI: (01)00884838004108(21)8524, (01)00884838004108(21)32039, (01)00884838004108(21)32052, (01)00884838004108(21)32083, (01)00884838004108(21)32087, (01)00884838004108(21)32097, (01)00884838004108(21)32103, (01)00884838004108(21)32118, (01)00884838004108(21)32123, (01)00884838004108(21)32150, (01)00884838004108(21)32153, 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(01)00884838055292(21)72190, (01)00884838055292(21)72192, (01)00884838055292(21)72201, (01)00884838055292(21)72204, (01)00884838055292(21)72208, (01)00884838055292(21)72222, (01)00884838055292(21)72239, (01)00884838055292(21)72240, (01)00884838055292(21)72247, (01)00884838055292(21)72290, (01)00884838055292(21)72306, (01)00884838055292(21)72322; Serial No. 21034, 21035, 21082, 21083, 21133, 21158, 21165, 21178, 21184, 21205, 21209, 21212, 21225, 21237, 21240, 21242, 21246, 21247, 21249, 21262, 21265, 21269, 21271, 21292, 21299, 21320, 21327, 21333, 21343, 21345, 21359, 21369, 21396, 21397, 21428, 21431, 21438, 21448, 21458, 21480, 21503, 21530, 21540, 21552, 21556, 21577, 21580, 21607, 21647, 21677, 21682, 21684, 21686, 21688, 21690, 21704, 21706, 21711, 21713, 21724, 21725, 21848, 21851, 21876, 21879, 21895, 21900, 21913, 21914, 21935, 21961, 21988, 21994, 21995, 21996, 22019, 22026, 22051, 22052, 22053, 22055, 22065, 22078, 22080, 22085, 22103, 22117, 22119, 22133, 22135, 22147, 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72322.", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "additional_info_contact": "Customer Care Solutions Center\n1-800-722-9377", "reason_for_recall": "Potential component failure in the Gradient Coil could product smoke and/or fire.", "root_cause_description": "Under Investigation by firm", "action": "The firm mailed URGENT Medical Device Correction Notices dated 10/23/2023 to consignees to notify them of this recall event. Consignees are instructed to identify if they possess any affected devices in their inventory and to follow the provided instructions for when scan aborts occur to prevent the failure mode associated with this recall event. Consignees are to stop the scan immediately and contact Philips Service if any of the failure situations outlined in the notice occur during a scan. Consignees are asked to complete and return the provided response form to Philips no later than 30 days after receipt of the recall notice. Questions can be directed to Customer Care Solutions at 1-800-722-9377.", "product_quantity": "520 units", "distribution_pattern": "Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.", "openfda": { "k_number": [ "K253808", "K241331", "K915395", "K033168", "K893881", "K230187", "K903527", "K921046", 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