{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 5 } }, "results": [ { "cfres_id": "166078", "product_res_number": "Z-2892-2018", "event_date_initiated": "2018-07-13", "event_date_created": "2018-08-22", "recall_status": "Open, Classified", "res_event_number": "80645", "product_code": "MHX", "k_numbers": [ "K070588" ], "product_description": "Philips SureSigns VSV (Vital Signs Viewer), 863067\n\nIndicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.", "code_info": "UDI# VSV (863067): 00884838009578", "firm_fei_number": "1218950", "recalling_firm": "Philips Electronics North America Corporation", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "Customer Service\n800-722-9377", "reason_for_recall": "Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited.\nThese batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles.\nAlthough the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.", "root_cause_description": "Labeling design", "action": "On July 13, 2018, the firm issued an \"URGENT-Medical Device Correction\" letter dated July 10, 2018, to affected customers to advise them that that monitors with batteries that have exceeded their specified replacement interval may overheat or ignite. The firm issued a Service Guide addendum included with the letter, which contains information to assist with managing the battery and its replacement.\n\nCustomers were advised to do the following:\n\nUpon receipt of this notification, carefully read the enclosed SureSigns Addendum to the Service Guide.\n VS Series Customers -Addendum to the Service Guide: 453564807541\n VM Series Customers -Addendum to the Service Guide: 453564807551\n VSV Customers- Addendum to the Service Guide: 453564815301\nPromptly perform the Battery Maintenance that is called out in the Addendum for each of your affected Philips SureSigns VS & VM Monitors and View Station (VSV) by determining if the Battery Information Screen indicates if the battery cycle count exceeds the limit of 300 cycles, or the battery is older than three (3) years. If so, the battery needs to be replaced. The replacement battery can be ordered using the standard Philips replacement processes.\nDetails on how to replace the battery can be found in the Philips SureSigns VS & VM Monitors and View Station (VSV) Service Guide.\nReview this information with all staff members who are responsible for device management of the Philips SureSigns VS & VM Monitors and View Station (VSV).\nPlease store the below Service Guide Addendum with your Philips SureSigns VS & VM Monitors and View Station (VSV) Service Guide documentation.\n VS Series Customers -Addendum to the Service Guide: 453564807541\n VM Series Customers -Addendum to the Service Guide: 453564807551\n VSV Customers- Addendum to the Service Guide: 453564815301\nComplete and return the response card provided.\n\nIn addition to providing the Service Guide Addendum and this notice, Philips plans to release a customer ins", "product_quantity": "VM 96,324 Units; VS 110,424 Units; VSV 691 Units", "distribution_pattern": "Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Afghanistan, Albania, Andorra, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bhutan, Bolivia, Brazil, Bulgaria, Canada, Cambodia, Chile, China, Colombia, Costa Rica, Cote D'Ivoire, Croatia, Czech Republic, Dominican Republic, El Salvador, Egypt, Estonia, Ethiopia, France, French Guiana, French Polynesia, Finland, Guadeloupe, Germany, Ghana, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Japan, Jordan, Kenya, Korea, Kosovo, Republic of, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Lybia, Macao, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, State of, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Zambia and Zimbabwe.", "openfda": { "k_number": [ "K130849", "K081891", "K082045", "K220308", "K143676", "K150082", "K151860", "K132075", "K190011", "K011000", "K000815", "K022889", "K102040", "K033304", "K040395", "K223498", "K012915", "K251702", "K945385", "K073462", "K160981", "K132533", "K023569", "K173036", "K100939", "K081983", "K923054", "K000854", "K990563", "K010923", "K153275", "K113623", "K050141", "K183387", "K011918", "K222586", "K130584", "K112962", "K192137", "K250453", "K062576", "K912188", "K101619", "K922974", "K082280", "K192972", "K110953", "K182075", "K260579", "K090443", "K122253", "K180482", "K102239", "K062144", "K061675", "K041741", "K023698", "K112803", "K100217", "K120616", "K031340", "K092680", "K060281", "K231671", "K100046", "K031760", "K040246", "K131223", "K093501", "K152407", "K150975", "K980411", "K041790", "K043439", "K152552", "K060833", "K033711", "K083228", 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