{ "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": "115317", "product_res_number": "Z-0824-2013", "event_date_initiated": "2013-01-14", "event_date_posted": "2013-02-14", "recall_status": "Terminated", "event_date_terminated": "2020-08-27", "res_event_number": "64070", "product_code": "DXN", "k_numbers": [ "K112652" ], "product_description": "Philips Healthcare SureSigns VS2+\nModel 863278 SureSigns VS2+ NBP and SpO2\nModel 863279 SureSigns VS2+ NBP, SpO2 and Temperature\n\nProduct Usage:\nThe SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. 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CN21204015, CN21204123, CN21204124, CN21204212, CN21204213, CN21204216, CN21204217, CN21204275, CN21204276, CN21204277, CN21204278, CN21204279, CN21204280, CN21204281, CN21204282, CN21204316, CN21204326, CN21204327, CN21204328, CN21204373, CN21204374, USPP3NCK10", "firm_fei_number": "1218950", "recalling_firm": "Philips Healthcare Inc.", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "Debra Levasseur\n978-659-4065", "reason_for_recall": "VS2+ screen may lock up and stop monitoring during patient use", "root_cause_description": "Software design", "action": "Philips issued an Urgent Medical Device Correction letter on January 14, 2013. The field action will take place in two phases: \n\nPhase 1 Philips sent customer an Urgent Medical Device Correction Notification/Field Safety Notice. This notification explains the issues and gives the customers instructions on actions to take while they await the hardware correction.\n\nPhase 2 Once the hardware correction Philips will contact customers and perform the correction free of charge. Until the correction is available.\nAffected products may continue to be used while waiting for the correction from Philips if the unit is not used in NBP interval mode.\n\nA Philips Healthcare representative will contact you to arrange for the correction of all affected devices. If you need any further information or support concerning this issue, please contact the Philips Customer Care Center at 1-800-722-9377.\n\nOn 3/14/13, firm stated Initially the fix would be a hardware upgrade but have since changed that to a software update. Customers within the US will be sent a new Field Safety Notice as well as a USB software update package and will be required to notify us upon the upgrade of their affected units. They will be performing the updates themselves", "product_quantity": "3248 units", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of: \nAUSTRALIA, AUSTRIA, BELGIUM,CANADA, CHILE, DENMARK, FRANCE\nGERMANY, ICELAND, INDIA, IRELAND,ISRAEL,ITALY, JORDAN, KENYA\nKUWAIT, LEBANON, MALAYSIA, NAMIBIA, NETHERLANDS, NEW ZEALAND\nNORWAY,PALESTINE, POLAND,PORTUGAL, SAUDI ARABIA, SINGAPORE\nSLOVENIA, SOUTH AFRICA, SOUTH KOREA,SPAIN,SWEDEN, SWITZERLAND\nTHAILAND, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES\nUNITED KINGDOM", "openfda": { "k_number": [ "K864737", "K082599", "K123669", "K890198", "K072272", "K882188", "K112269", "K131749", "K052153", "K994423", "K170466", "K062033", "K112690", "K151127", "K120675", "K131064", "K881269", "K032499", "K040309", "K823052", "K830338", "K200346", "K800662", "K081654", "K870049", "K871418", "K870460", "K912118", "K792194", "K042138", "K171937", "K000500", "K120673", "K130232", "K143734", "K090768", "K190886", "K170454", 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