{ "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": "86325", "product_res_number": "Z-0372-2010", "event_date_initiated": "2009-10-30", "event_date_posted": "2009-11-23", "recall_status": "Terminated", "event_date_terminated": "2013-02-20", "res_event_number": "53688", "product_code": "MHX", "k_numbers": [ "K090483" ], "product_description": "SureSigns Patient Monitors (VM3, VM4. VM6. VM8):\nVM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4\"display \n\nVM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4\" display \n\nVM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4\" display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4\" display \n\nVM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2, SPo2 Bedside Patient Monitor with 10\" display or 3/5 Lead ECG, NBP, Temp, IPB, SPo2 Bedside Patient Monitor with 10\" display \n\nPart number: \nVM3:\n863077,453564041661,453564050161,\nVM4:\n863063,453564024371,453564021961,\n453564024401,453564021971\nVM6:\n863064,863065,453564024421,453564022001,\n453564024441\nVM8:\n453564022041,863066,863068,453564022081, 453564024461, 453564024481\n\nThe SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.", "code_info": "Software Versions: A.01.51, A.01.45, A.01.42, A.01.40, A.00.58, A.00.55, A.00.52, A.00.51, and A.00.41", "firm_fei_number": "1218950", "recalling_firm": "Philips Healthcare Inc.", "address_1": "3000 Minuteman Road", "city": "Andover", "state": "MA", "postal_code": "01810", "additional_info_contact": "978-687-1501", "reason_for_recall": "Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker", "root_cause_description": "Software design", "action": "Customer notifications dated October 2009, in the United States will be delivered via UPS. Customer notifications outside the US will be managed by Philips representatives in each affected geography. \n\nCustomers will be instructed to lower the volume setting while using existing units during the first notification. As part of the second notification to the customers, the field action correction will be a customer installable software upgrade. Customers may contact Philips Response Center with questions or concerns at 1.800.722.9377.\n\nOn December 14, the firm issued the follow-up notification letter implementing the action plan to provide the software upgrade kit for installation and instructions.", "product_quantity": "30, 833 units", "distribution_pattern": "Nationwide \nForeign: Canada\nAfghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegowina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates", "openfda": { "k_number": [ "K100040", "K063725", "K130711", "K131414", "K250854", "K013199", "K112190", "K151812", "K031320", "K123556", "K132075", "K060223", "K060135", "K221056", "K101449", "K990563", "K120598", "K240320", "K132533", "K153275", "K223531", "K211900", "K170514", "K112803", "K914838", "K070566", "K062324", "K021325", "K173036", "K031376", "K141963", "K933624", "K192972", "K082045", "K993608", "K950436", "K000815", "K043439", "K141156", 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