{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "205345", "product_res_number": "Z-0715-2024", "event_date_initiated": "2021-07-15", "event_date_posted": "2024-01-11", "recall_status": "Open, Classified", "res_event_number": "93739", "product_code": "LNI", "k_numbers": [ "K213583" ], "product_description": "(1) Ingenia Ambition X (Product Number 781356);\n(2) Ingenia Ambition S (Product Number 781359)", "code_info": "(1) Ingenia Ambition X\nUDI-DI 00884838090040\nSerial Numbers\n47000\n47001\n47002\n47003\n47004\n47006\n47007\n47009\n47011\n47012\n47013\n47014\n47015\n47016\n47017\n47018\n47019\n47020\n47022\n47023\n47024\n47025\n47026\n47027\n47028\n47029\n47030\n47032\n47033\n47034\n47035\n47037\n47038\n47039\n47040\n47041\n47043\n47044\n47045\n47047\n47048\n47049\n47050\n47051\n47052\n47053\n47054\n47056\n47057\n47058\n47059\n47060\n47061\n47062\n47063\n47064\n47065\n47066\n47067\n47068\n47070\n47071\n47072\n47074\n47075\n47077\n47078\n47080\n47081\n47082\n47083\n47084\n47085\n47088\n47089\n47091\n47092\n47093\n47094\n47095\n47096\n47097\n47098\n47099\n47174\n47175\n47177\n47183\n47184\n47187\n47188\n47190\n47192\n47193\n47194\n47195\n47196\n47197\n47198\n47199\n47202\n47203\n47206\n47208\n47209\n47211\n47215\n47216\n47219\n47220\n47221\n47225\n47226\n47227\n47244\n47245\n47247\n47248\n47252\n47255\n47258\n47260\n47262\n47268\n47269\n47270\n47271\n47272\n47275\n47276\n47279\n47284\n47297\n47298\n47282\n\n(2) Ingenia Ambition S\nUDI-DI 00884838090057\nSerial Numbers\n48000\n48001\n48003\n48004\n48005\n48009\n48010\n48011\n48012\n48013\n48014\n48015\n48016\n48017\n48018\n48019\n48020\n48022\n48023\n48026\n48027\n48028\n48031\n48032\n48033\n48034\n48035\n48036\n48037\n48038\n48039\n48040\n48043\n48044\n48045\n48046\n48047\n48049\n48050\n48051\n48052\n48053\n48055\n48056\n48112\n48120\n48122\n48127\n48128\n48129\n48130\n48131\n48133\n48134\n48136\n48144\n48148\n48151\n48152\n48153\n48154\n48155\n48158\n48160\n48162\n48166\n48167\n48169\n48171\n48172\n48173\n48174\n48179\n48180\n48181\n48182\n48183\n48184\n48186\n48187\n48188\n48190\n48191\n48192\n48194\n48196\n48198\n48199\n48200\n48207", "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\n800-722-9377", "reason_for_recall": "The sealed magnet will experience uncontrolled shutdown known as Loss-of-Field (LoF) if the magnet loses cryo-cooling (e.g. caused by a power outage on site.)", "root_cause_description": "Process change control", "action": "Starting in July 2021, Philips Field Service Engineers (FSE) visited impacted customer sites to inspect the affected systems and turn on the circuit breaker of the extended battery of the UPS where required. All impacted systems were addressed as of February 9, 2023.\n\nInstructions for manufacturing and installation were updated on October 31, 2020, which included more detailed instructions for the correct setting of the circuit breaker.", "product_quantity": "56 US; 169 ROW", "distribution_pattern": "Domestic distribution to the following states and territories: CA\nDE\nFL\nGA\nIL\nKY\nMA\nME\nMI\nMO\nNH\nNJ\nNM\nNY\nOH\nPA\nSC\nTN\nTX\nVA\nVT\nWI\nWY, and PR.\n\nInternational distribution worldwide.", "openfda": { "k_number": [ "K930265", "K010129", "K970005", "K011604", "K962627", "K984167", "K071506", "K003575", "K991568", "K093044" ], "registration_number": [ "", "3005877899", "3002808157", "3035371452", "3036666444", "3035950510", "3010326005", "3012169560", "3018423337", "1529041", "3003768277", "3005810333", "3000126629", "3016851825", "3042177665", "9616047", "3017375271", "9613936", "3033527281", "3012127758", "3009154005", "2183553", "3027339477", "3009196578", "3010949642", "3009077524", "3031503890", "3008632256", "3010398867", "3015276088", "3008284470", "3004754211", "3005049692", "3012939903", "3004531751", "3023003446", "3007562060", "3013875850", "3007350713", "3008447096", "3011416394", "3015329423", "3005326970", "3021059265", "3032109225", "3026047529", "3032109181", "3008355361", "3012085143", "3029521953", "3014343100" ], "fei_number": [ "", "3005877899", "3002808157", "3035371452", "3036666444", "3035950510", "3010326005", "3012169560", "3018423337", "3005810333", "3000126629", "3002807880", "3016851825", "3042177665", "3017375271", "3033527281", "3003377038", "3012127758", "3009154005", "2183553", "3027339477", "3009196578", "3010949642", "3009077524", "3031503890", "3008632256", "3010398867", "3015276088", "3008284470", "3005214683", "3005049692", "3012939903", "3004531751", "3023003446", "3007562060", "3004754211", "1000571342", "3013875850", "3007350713", "3008447096", "3011416394", "3015329423", "3005326970", "3021059265", "3032109225", "3026047529", "3032109181", "3008355361", "3012085143", "3029521953", "3014343100" ], "device_name": "System, Nuclear Magnetic Resonance Spectroscopic", "medical_specialty_description": "Radiology", "regulation_number": "892.1000", "device_class": "2" } } ] }