{ "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. 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801, 46, 2029, 2028, 3229, 3776, 1415, 2162, 3250, 3445, 2598, 1258, 2791.", "firm_fei_number": "3002807880", "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "address_1": "Veenpluis 4-6 4-6 veenpluis", "city": "Best", "country": "Netherlands", "additional_info_contact": "Virginia Huete\n31-615-67 92 27", "reason_for_recall": "Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure.", "root_cause_description": "Under Investigation by firm", "action": "On October 7, 2024 URGENT MEDICAL DEVICE CORRECTION letters were sent to consignees. 4. Actions that should be taken by the customer! user in order to prevent risks for patients.\n\" Affected systems may continue to be used in accordance with their intended use and\nInstructions for Use (IFU).\n\" Establish emergency protocols including back up devices if available in place to manage the\nsituation should you experience this issue during the procedure.\n\" Circulate this Urgent Medical Device Correction to all users of the system so that they are aware\nof the issue.\n\" Keep this Urgent Medical Device Correction with the documentation of the system until Philips\nimplements the correction in your system. Ensure that the letter is in a place likely to be seen!\nviewed.\n\" If you experience a power loss issue with your system, report the event to Philips.\n\" Complete and return the attached response form (on page 04) to Philips promptly and no later\nthan 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device\nCorrection and understanding of the issue and required actions to be taken.\n5. Actions planned by Philips IGT (Image Guided Therapy) systems to correct the problem\nPhilips will replace the 5-Ampere MCU board fuse with a 10-Ampere MCU board fuse in all affected\nsystems.\nPhilips will contact customers to schedule a visit to perform this action free of charge (reference\nFC071800109).\nThis notice has been reported to the appropriate Regulatory Agencies. Adverse reactions or quality\nproblems experienced with the use of this product may be reported to the FDA s MedWatch Adverse\nEvent Reporting program either online, or by regular mail, or by fax.\nBe assured that maintaining a high level of safety and quality is our highest priority. If you need\nadditional information or support concerning this issue, contact your local Philips representative at\n1800-722-9377 (Philips Customer Care Solutions Center).", "product_quantity": "2,247 units (582 US, 84 Canada, 1,581 R.O.W.)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kuwait, Lao People's Democratic Republic, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mauritius, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, State of, Panama, Peru, Philippines, Poland, Portugal, R¿union, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Viet Nam, Yemen.", "openfda": { "k_number": [ "K133580", "K022069", "K982993", "K240099", "K222080", "K254173", "K093066", "K221922", "K252735", "K002016", "K123508", "K013608", "K142736", "K113027", "K181943", "K130638", "K060259", "K200917", "K070834", "K170752", "K120073", "K103425", "K936180", "K181670", "K030544", "K183144", "K201172", "K041605", "K251199", "K252068", "K190768", "K221281", "K212159", "K243328", "K200022", "K152696", "K212557", "K260607", "K251523", "K142126", "K211191", "K133292", "K961374", "K190064", "K152697", "K923049", "K221335", "K240465", "K252229", "K211782", "K241572", "K921219", "K000221", "K240224", "K160279", "K200887", "K222070", "K183101", "K122234", "K211064", 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