{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196075", "product_res_number": "Z-0004-2023", "event_date_initiated": "2022-09-06", "event_date_posted": "2022-10-04", "recall_status": "Open, Classified", "res_event_number": "90857", "product_code": "MWI", "k_numbers": [ "K212227" ], "product_description": "MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561\n\nThis is a component of product number 866162.", "code_info": "01.02.00 - United States, Puerto Rico, Guam\n01.01.00 - ROW\nUDI-DI: 00884838091948\nImpacted serial numbers:\nUS04100115\nUS04100116\nUS04100117\nUS04100118\nUS04100119\nUS04100120\nUS04100121\nUS04100122\nUS04100123\nUS04100124\nUS04100125\nUS04100126\nUS04100127\nUS04100128\nUS04100129\nUS04100130\nUS04100131\nUS04100132\nUS04100134\nUS04100135\nUS04100137\nUS04100138\nUS04100139\nUS04100140\nUS04100141\nUS04100142\nUS04100143\nUS04100144\nUS04100145\nUS04100146\nUS04100147\nUS04100148\nUS04100150\nUS04100151\nUS04100152\nUS04100154\nUS04100155\nUS04100156\nUS04100157\nUS04100158\nUS04100159\nUS04100160\nUS04100161\nUS04100162\nUS04100163\nUS04100164\nUS04100165\nUS04100166\nUS04100167\nUS04100168\nUS04100169\nUS04100170\nUS04100171\nUS04100172\nUS04100173\nUS04100174\nUS04100175\nUS04100177\nUS04100178\nUS04100179\nUS04100182\nUS04100185\nUS04100187\nUS04100189\nUS04100190\nUS04100191\nUS04100192\nUS04100193\nUS04100194\nUS04100195\nUS04100196\nUS04100197\nUS04100200\nUS04100201\nUS04100202\nUS04100203\nUS04100204\nUS04100205\nUS04100207\nUS04100208\nUS04100209\nUS04100210\nUS04100211\nUS04100213\nUS04100214\nUS04100215\nUS04100216\nUS04100217\nUS04100218\nUS04100219\nUS04100220\nUS04100221\nUS04100222\nUS04100224\nUS04100225\nUS04100226\nUS04100227\nUS04100228\nUS04100229\nUS04100230\nUS04100231\nUS04100232\nUS04100233\nUS04100234\nUS04100235\nUS04100237\nUS04100238\nUS04100239\nUS04100240\nUS04100241\nUS04100242\nUS04100244\nUS04100245\nUS04100246\nUS04100247\nUS04100248\nUS04100250\nUS04100251\nUS04100252\nUS04100253\nUS04100254\nUS04100255\nUS04100256\nUS04100257\nUS04100258\nUS04100260\nUS04100261\nUS04100262\nUS04100263\nUS04100264\nUS04100266\nUS04100267\nUS04100268\nUS04100269\nUS04100270\nUS04100271\nUS04100272\nUS04100273\nUS04100274\nUS04100275\nUS04100276\nUS04100277\nUS04100278\nUS04100279\nUS04100280\nUS04100282\nUS04100284\nUS04100285\nUS04100286\nUS04100287\nUS04100288\nUS04100289\nUS04100290\nUS04100292\nUS04100293\nUS04100294\nUS04100295\nUS04100296\nUS04100297\nUS04100298\nUS04100299\nUS04100300\nUS04100302\nUS04100303\nUS04100304\nUS04100305\nUS04100306\nUS04100307\nUS04100309\nUS04100310\nUS04100311\nUS04100312\nUS04100313\nUS04100314\nUS04100317\nUS04100318\nUS04100319\nUS04100320\nUS04100321\nUS04100322\nUS04100323\nUS04100324\nUS04100326\nUS04100327\nUS04100328\nUS04100329\nUS04100330\nUS04100331\nUS04100332\nUS04100333\nUS04100334\nUS04100335\nUS04100337\nUS04100338\nUS04100340\nUS04100341\nUS04100342\nUS04100343\nUS04100344\nUS04100346\nUS04100347\nUS04100349\nUS04100350\nUS04100351\nUS04100352\nUS04100353\nUS04100354\nUS04100356\nUS04100357\nUS04100358\nUS04100359\nUS04100360\nUS04100361\nUS04100362\nUS04100363\nUS04100364\nUS04100365\nUS04100367\nUS04100368\nUS04100369\nUS04100370\nUS04100371\nUS04100372\nUS04100373\nUS04100374\nUS04100375\nUS04100376\nUS04100377\nUS04100378\nUS04100379\nUS04100381\nUS04100383\nUS04100384\nUS04100385\nUS04100386\nUS04100387\nUS04100388\nUS04100389\nUS04100390\nUS04100391\nUS04100392\nUS04100393\nUS04100394\nUS04100395\nUS04100396\nUS04100397\nUS04100398\nUS04100399\nUS04100400\nUS04100401\nUS04100402\nUS04100403\nUS04100404\nUS04100405\nUS04100406\nUS04100407\nUS04100409\nUS04100411\nUS04100412\nUS04100413\nUS04100414\nUS04100416\nUS04100419\nUS04100420\nUS04100421\nUS04100422\nUS04100423\nUS04100424\nUS04100425\nUS04100426\nUS04100427\nUS04100428\nUS04100429\nUS04100430\nUS04100431\nUS04100432\nUS04100433\nUS04100459\nUS04100616\nUS04100619\nUS04100620\nUS04100621\nUS04100623\nUS04100624\nUS04100626\nUS04100627\nUS04100628\nUS04100630\nUS04100631\nUS04100632\nUS04100634\nUS04100635\nUS04100637\nUS04100638\nUS04100639\nUS04100640\nUS04100642\nUS04100643\nUS04100644\nUS04100646\nUS04100647\nUS04100648\nUS04100649\nUS04100807\nUS04100811\nUS04100818\nUS04100821\nUS04100828", "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": "Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.", "root_cause_description": "Under Investigation by firm", "action": "On September 6, 2022, Philips notified affected customers through URGENT Medical Device Recall letters.\n\nA Philips representative will contact customers to arrange a software update. once arranged, a Philips representative will conduct a software update on the device for the customer.\n\nCustomers should share the recall information with all clinical staff to review and understand. The notice should be placed with the documentation of the MR Patient Care Portal 5000.", "product_quantity": "115 US; 193 ROW", "distribution_pattern": "Domestic distribution to AL\nAZ\nCA\nCO\nFL\nGA\nID\nIL\nIN\nLA\nMA\nMI\nMN\nNC\nNE\nNJ\nOH\nPA\nSC\nTN\nTX\nUT\nVT\nWA\nWY.\n\nForeign distribution to Australia\nAustria\nBelgium\nCzech Republic\nDenmark\nEstonia\nFinland\nFrance\nGermany\nIreland\nItaly\nMalta\nNetherlands\nNorway\nPoland\nPortugal\nQatar\nSingapore\nSlovakia\nSpain\nSweden\nSwitzerland\nUnited Kingdom", "openfda": { "k_number": [ "K112877", "K071645", "K134014", "K072516", "K170798", "K200856", "K032749", "K142106", "K132807", "K153335", "K142840", "K033283", "K143751", "K112329", "K043368", "K101259", "K142356", "K212161", "K172200", "K050399", "K181541", "K041918", "K033030", "K181311", "K031863", "K162234", "K210204", "K122036", "K131762", "K081552", "K233133", "K153225", "K110503", "K071802", "K140188", "K143304", "K033672", "K130740", "K200160", "K120193", 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