{ "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": "66252", "product_res_number": "Z-0451-2008", "event_date_initiated": "2007-11-13", "event_date_posted": "2007-12-11", "recall_status": "Terminated", "event_date_terminated": "2016-08-15", "res_event_number": "45843", "product_code": "MHX", "k_numbers": [ "K062271" ], "product_description": "Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810", "code_info": "Serial Numbers: 4711A00132 4725A02724 4711A00354\t4725A02791 4716A00562\t4725A02897 4717A00702\t4725A02927 4717A00703\t4725A03255 4717A00705\t4732A03719 4717A00706\t4732A03725 4717A00724\t4732A03764 4717A00725\t4732A03765 4717A00799\t4732A03766 4717A00857\t4732A04028 4718A00957\t4732A04031 4718A01077\t4732A04134 4718A01078\t4732A04178 4718A01120\t4732A04400 4718A01121\t4732A04623 4718A01454\t4732A04671 4721A01670\t4732A04675 4721A01711\t4732A04746 4721A01731\t4732A04868 4721A01773\t4732A04869 4721A01797\t4732A04870 4721A01828\t4732A04871 4721A01919\t4732A04872 4721A01993\t4732A04873 4721A01994\t4732A04874 4721A01997\t4732A04875 4721A02164\t4732A04876 4725A02354\t4732A04877 4732A04890 4732A04896", "firm_fei_number": "1218950", "recalling_firm": "Philips Medical Systems", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "SAME\n978-687-1501", "reason_for_recall": "Alarm failure : If changes are made to the Caregroup Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group", "root_cause_description": "Software change control", "action": "Philips Medical notified customers by letter dated November 2007 titled : Urgent Medical Device Correction Notice. Customers will be instructed to follow the Procedure to Mitigate Risk section * of the notice while they await the correction of their devices with a mandatory software upgrade to be performed by service representatives. * (no changes are to be made to the Caregroup Editor configuration on any system. If changes have already been made to the configuration prior to receipt of this notification, turn each bedside monitor \"off \" and then \"on\" in order to reset the system-Customer Care Contact telephone 1-800-722-9377)", "product_quantity": "60 units", "distribution_pattern": "Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom.", "openfda": { "k_number": [ "K191106", "K112190", "K242962", "K122439", "K053121", "K061993", "K051217", "K050742", "K113657", "K103646", "K150329", "K030431", "K191769", "K073203", "K223574", "K033365", "K132533", "K221879", "K240320", "K061379", "K101692", "K992929", "K070566", "K120173", "K213490", "K033694", "K060135", "K053484", "K073280", "K970445", "K232962", "K101067", "K253170", "K945385", "K150030", "K250349", "K123472", "K000517", "K120631", "K922210", 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