{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "64414", "product_res_number": "Z-0124-2008", "event_date_initiated": "2007-09-12", "event_date_posted": "2008-01-30", "recall_status": "Terminated", "event_date_terminated": "2016-08-16", "res_event_number": "44824", "product_code": "DPS", "k_numbers": [ "K020708" ], "product_description": "Philips PageWriter Touch Cardiograph,\nModel: 860284, Philips Medical Systems, Andover, MA, 01810", "code_info": "Serial Numbers:  US10603477\tUS60711180\tUS70711234\tUS80711276\tUS80711348\tUS80711386\tUS80711459 US10603478\tUS60711181\tUS70711235\tUS80711283\tUS80711349\tUS80711387\tUS80711460 US10603491\tUS60711182\tUS70711236\tUS80711284\tUS80711350\tUS80711388\tUS80711461 US10603493\tUS60711183\tUS70711241\tUS80711285\tUS80711351\tUS80711389\tUS80711462 US10603494\tUS60711184\tUS80503039\tUS80711286\tUS80711352\tUS80711390\tUS80711463 US10603495\tUS60711185\tUS80503049\tUS80711287\tUS80711353\tUS80711391\tUS90503082 US10603496\tUS60711186\tUS80711244\tUS80711288\tUS80711354\tUS80711392\tUS90503117 US10603497\tUS70711197\tUS80711245\tUS80711289\tUS80711355\tUS80711393\tUS90503119 US10603498\tUS70711199\tUS80711246\tUS80711290\tUS80711356\tUS80711394\tUS90503120 US10603499\tUS70711201\tUS80711247\tUS80711291\tUS80711357\tUS80711395\tUS90503121 US10603530\tUS70711205\tUS80711248\tUS80711292\tUS80711358\tUS80711396\tUS90503126 US10710463\tUS70711207\tUS80711249\tUS80711293\tUS80711359\tUS80711398\tUS90503127 US10710464\tUS70711208\tUS80711250\tUS80711294\tUS80711360\tUS80711399\tUS90503128 US10710465\tUS70711209\tUS80711251\tUS80711295\tUS80711361\tUS80711400\tUS90503129 US50502760\tUS70711210\tUS80711252\tUS80711296\tUS80711362\tUS80711402\tUS90503143 US50710968\tUS70711211\tUS80711253\tUS80711297\tUS80711363\tUS80711403\tUS90503148 US60502824\tUS70711212\tUS80711254\tUS80711298\tUS80711364\tUS80711404\tUS90503149 US60502825\tUS70711213\tUS80711255\tUS80711299\tUS80711365\tUS80711405\tUS90503150 US60502826\tUS70711214\tUS80711256\tUS80711300\tUS80711366\tUS80711406\tUS90503151 US60711064\tUS70711215\tUS80711257\tUS80711301\tUS80711367\tUS80711407\tUS90503152 US60711065\tUS70711216\tUS80711258\tUS80711302\tUS80711368\tUS80711408\tUS90503153 US60711067\tUS70711217\tUS80711259\tUS80711303\tUS80711369\tUS80711409\tUS90503154 US60711068\tUS70711218\tUS80711260\tUS80711304\tUS80711370\tUS80711411\tUS90503155 US60711070\tUS70711219\tUS80711261\tUS80711305\tUS80711371\tUS80711412\tUS90503156 US60711071\tUS70711220\tUS80711262\tUS80711306\tUS80711372\tUS80711413\tUS90503157 US60711073\tUS70711221\tUS80711263\tUS80711307\tUS80711373\tUS80711416\tUS90503158 US60711074\tUS70711222\tUS80711264\tUS80711308\tUS80711374\tUS80711417\tUS90503159 US60711075\tUS70711223\tUS80711265\tUS80711309\tUS80711375\tUS80711418\tUSD0301315 US60711076\tUS70711224\tUS80711266\tUS80711310\tUS80711376\tUS80711419\tUSD0610313 US60711077\tUS70711225\tUS80711267\tUS80711339\tUS80711377\tUS80711420\tUSN0301134 US60711078\tUS70711226\tUS80711268\tUS80711340\tUS80711378\tUS80711421\tUSN0400155 US60711079\tUS70711227\tUS80711269\tUS80711341\tUS80711379\tUS80711422\tUSN0402121 US60711080\tUS70711228\tUS80711270\tUS80711342\tUS80711380\tUS80711431\tUSN0402126 US60711081\tUS70711229\tUS80711271\tUS80711343\tUS80711381\tUS80711439\tUSN0402127 US60711176\tUS70711230\tUS80711272\tUS80711344\tUS80711382\tUS80711440\tUSN0402128 US60711177\tUS70711231\tUS80711273\tUS80711345\tUS80711383\tUS80711455\tUSN0402129 US60711178\tUS70711232\tUS80711274\tUS80711346\tUS80711384\tUS80711457\tUSN0610295 US60711179\tUS70711233\tUS80711275\tUS80711347\tUS80711385\tUS80711458\tand USO0610104", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "Steve Smyth\n978-687-1501", "reason_for_recall": "Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.", "root_cause_description": "Software change control", "action": "Philips Medical Systems notified affected customers by Customer Letter and Urgent - Device Correction Notice dated 9/12/07. The correction will be a software upgrade. In the US, the Philips Response Center will contact US customers and arrange their upgrades, either via a software download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until new software is installed, customers are being advised to use the 12 lead module, and to disable or disconnect the 16 lead connection.", "product_quantity": "266 units", "distribution_pattern": "Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE.", "openfda": { "k_number": [ "K802113", "K864465", "K884896", "K060167", "K103765", "K101115", "K842944", "K221321", "K802190", "K850323", "K830566", "K160092", "K110266", "K974746", "K042177", "K901948", "K182790", "K953415", "K011177", "K832421", "K152384", "K200036", "K112135", "K800659", "K002473", "K934439", "K930558", "K830791", "K900700", "K251670", "K922927", "K833951", "K092663", "K110065", "K131572", "K230834", "K881328", "K955416", "K200884", "K901771", "K160746", "K182093", "K152043", "K143432", "K800593", "K062894", "K924544", "K841611", "K832013", "K073625", "K791795", "K810357", "K833458", "K232823", "K212278", "K864504", "K935394", "K980362", "K870926", 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