{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 12 } }, "results": [ { "cfres_id": "188782", "product_res_number": "Z-2411-2021", "event_date_initiated": "2021-08-11", "event_date_created": "2021-09-03", "recall_status": "Completed", "res_event_number": "88491", "product_code": "LNH", "k_numbers": [ "K110151" ], "product_description": "Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities \nModels:\n781341\n781396", "code_info": "Model: 781341\nSerial Number\tUnique Device Identifier 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781396\n41146 Unique Device Identifier (UDI#)-N/A\n41318\n41472\n41564\n41176\n41175\n41253\n41282\n41492\n41485\n41026\n41132\n41130\n41200\n41398\n41061\n41007\n41039\n41157\n41181\n41127\n41262\n41256\n41350\n41378\n41510\n41541\n41567\n41012\n41505\n41230\n41268\n41186\n41359\n41441\n41459\n41460\n41271\n41521\n41556\n41584\n41236\n41302\n41343\n41204\n41449\n41011\n41138\n41259\n41440\n41531\n41151\n41524\n41518\n41297\n41595\n41610\n41612\n41615\n41617\n41619\n41618\n41509\n41591\n41103\n41105\n41043\n41010\n41085\n41024\n41029\n41016\n41052\n41031\n41055\n41071\n41119\n41017\n41125\n41025\n41112\n41051\n41141\n41139\n41192\n41084\n41145\n41160\n41211\n41142\n41210\n41227\n41131\n41218\n41240\n41286\n41284\n41283\n41288\n41349\n41144\n41266\n41239\n41261\n41368\n41375\n41338\n41373\n41402\n41390\n41228\n41327\n41367\n41412\n41432\n41433\n41395\n41383\n41454\n41389\n41388\n41392\n41442\n41381\n41380\n41417\n41471\n41424\n41473\n41143\n41538\n41561\n41553\n41235\n41045\n41118\n41314\n41397\n41108\n41366\n41519\n41436\n41070\n41330\n41465\n41470\n41491\n41172\n41162\n41255\n41254\n41446\n41515\n41047\n41020\n41114\n41169\n41168\n41196\n41260\n41178\n41351\n41363\n41498\n41464\n41520\n41500\n41523\n41522\n41088\n41089\n41041\n41054\n41226\n41287\n41328\n41336\n41384\n41387\n41355\n41334\n41423\n41189\n41371\n41376\n41335\n41453\n41548\n41573\n41038\n41480\n41050\n41113\n41096\n41086\n41087\n41093\n41129\n41184\n41163\n41161\n41213\n41201\n41202\n41217\n41220\n41193\n41234\n41233\n41246\n41257\n41258\n41267\n41310\n41199\n41337\n41332\n41344\n41352\n41399\n41365\n41411\n41422\n41469\n41474\n41499\n41489\n41502\n41494\n41545\n41568\n41574\n41535\n41074\n41068\n41042\n41060\n41049\n41064\n41106\n41133\n41109\n41124\n41126\n41164\n41153\n41174\n41128\n41136\n41244\n41275\n41243\n41272\n41290\n41281\n41280\n41292\n41298\n41117\n41299\n41329\n41339\n41229\n41361\n41357\n41362\n41428\n41408\n41452\n41457\n41496\n41437\n41435\n41488\n41493\n41513\n41400\n41543\n41544\n41549\n41507\n41559\n41490\n41570\n41565\n41572\n41534\n41558\n41571\n41099\n41182\n41232\n41231\n41497\n41547\n41563\n41300\n41583\n41592\n41115\n41405\n41180\n41185\n41293\n41458\n41466\n41467\n41560\n41001\n41013\n41100\n41008\n41140\n41187\n41191\n41225\n41190\n41214\n41249\n41456\n41413\n41461\n41450\n41301\n41033\n41080\n41167\n41216\n41215\n41486\n41364\n41372\n41304\n41527\n41340\n41289\n41075\n41306\n41540\n41562\n41107\n41152\n41219\n41296\n41331\n41309\n41394\n41546\n41575\n41588\n41120\n41137\n41111\n41110\n41295\n41594\n41407\n41177\n41179\n41241\n41279\n41578\n41478\n41577\n41155\n41419\n41536\n41069\n41021\n41000\n41036\n41037\n41044\n41005\n41006\n41059\n41066\n41067\n41009\n41083\n41035\n41028\n41090\n41034\n41095\n41023\n41015\n41077\n41022\n41057\n41048\n41018\n41056\n41046\n41091\n41073\n41116\n41097\n41104\n41079\n41149\n41092\n41123\n41098\n41159\n41154\n41158\n41173\n41094\n41188\n41148\n41166\n41171\n41205\n41206\n41198\n41212\n41208\n41134\n41197\n41203\n41195\n41194\n41250\n41242\n41209\n41221\n41251\n41237\n41263\n41303\n41222\n41312\n41313\n41265\n41278\n41291\n41370\n41342\n41294\n41311\n41406\n41354\n41438\n41418\n41427\n41358\n41425\n41426\n41356\n41475\n41434\n41415\n41420\n41277\n41444\n41421\n41462\n41495\n41512\n41409\n41463\n41516\n41429\n41482\n41305\n41511\n41525\n41517\n41484\n41514\n41532\n41551\n41481\n41552\n41580\n41569\n41555\n41590\n41238\n41224\n41319\n41526\n41082\n41414\n41479\n41476\n41477", "firm_fei_number": "3016618143", "recalling_firm": "Philips North America Llc", "address_1": "222 Jacobs St", "city": "Cambridge", "state": "MA", "postal_code": "02141-2289", "reason_for_recall": "When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment", "root_cause_description": "Device Design", "action": "Philips notified U.S. customers an Urgent Medical Device Correction letter on 8/11/21. Letter states reason for recall, health risk and action to take:\nPhilips advises that customers continue to utilize the primary motorized function for the MR system since the identified issue with the HDU does not occur in the motorized mode. If you utilize the manual function and it is not functioning properly, then you must perform table movement using the motorized function.\nA Philips Field Service Engineer (FSE) will perform a HDU during the next scheduled preventive maintenance visit. If the issue is detected in the HDU, the Philips FSE will replace the necessary mechanical component(s) to resolve the issue.\nIf you need additional information or support concerning this issue, please contact the Customer Care Solutions Center (1-800-722-9377) and reference FCO78100527.", "product_quantity": "1517 units, 488 units", "distribution_pattern": "Worldwide distribution - US Nationwide distribution and the countries of Albania, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belarus, Belgium\nBolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, \nEgypt, Estonia, Finland, France, French Guiana, Georgia, Germany, Ghana, Greece, Guadeloupe, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, \nJapan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, \nLao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Luxembourg, \nMacedonia, Malaysia, Maldives, Malta, Martinique, Mauritius, Mayotte, Mexico, Moldova,\nMonaco, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan\nPalestine, State of Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, \nQatar, R¿union, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, \nSlovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, \nTaiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Viet Nam.", "openfda": { "k_number": [ "K903754", "K033168", "K120638", "K903319", "K192426", "K913463", "K120748", "K896419", "K892959", "K182129", "K912095", "K915567", "K192650", "K930779", "K101295", "K943021", "K141945", "K123522", "K242524", "K903527", "K203553", "K133670", "K161567", "K253625", "K971380", "K043030", "K924489", "K905634", "K933658", "K923870", "K232361", "K940514", "K933295", "K914019", 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