{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191569", "product_res_number": "Z-0647-2022", "event_date_initiated": "2021-12-02", "event_date_created": "2022-02-17", "recall_status": "Open, Classified", "res_event_number": "89437", "product_code": "OWB", "k_numbers": [ "K183101" ], "product_description": "Zenition 50, Model #718096", "code_info": "Wireless Foot switch 3P : 459801238191  Wireless Foot switch 3P: 459801238231", "firm_fei_number": "3002807880", "recalling_firm": "PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.", "address_1": "Veenpluis 4-6 4-6 veenpluis", "city": "Best", "country": "Netherlands", "reason_for_recall": "Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.", "root_cause_description": "Under Investigation by firm", "action": "On December 2, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. \n\nThe Medical Device Correction includes the following instructions for the Customer:\n\no\tEnsure that the wired foot switch is always connected to the system. \no\tImmediately start using the wired foot switch or hand switch in the event the wireless foot switch loses connection. \no\tPerform a daily check for damage and correct functioning of the hand switch and wired foot switch as described by the User Routine Checks section in your Instruction for Use. \no\tCirculate this notice to all users of this device so that they are aware of the issue./ \no\tPlace this Medical Device Correction with the documentation of the Philips Zenition 50, Zenition 70 or Veradius Unity system. \no\tReturn the attached reply form to Philips to confirm that:\n1. The Zenition 50, Zenition 70 and Veradius Unity systems wired foot switch is connected to the system \n2. The users of the system have reviewed and understood this Medical Device Correction. \n\n\nIf you need further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377.", "product_quantity": "16 US; 76 ROW", "distribution_pattern": "Domestic distribution to\nAZ\nCA\nFL\nGA\nHI\nIL\nKS\nKY\nMA\nMD\nME\nMI\nMN\nMS\nNC\nNE\nNJ\nNV\nNY\nOH\nPA\nTN\nTX\nVA\nWA\nWV. Worldwide foreign distribution.", "openfda": { "k_number": [ "K231692", "K183109", "K251523", "K210900", "K171829", "K232344", "K021049", "K032761", "K240199", "K051064", "K212523", "K092004", "K200917", "K133278", "K202547", "K220946", "K173736", "K181550", "K982993", "K200074", "K212212", "K032046", "K252099", "K041931", "K212159", "K993037", "K160279", "K130893", "K230871", "K181670", "K260607", "K961105", "K182415", "K181407", "K190768", "K172180", "K150967", "K061173", "K212383", "K092438", "K222998", "K141979", "K163286", "K181830", "K251893", "K193230", "K132094", "K171565", "K243303", "K172863", "K061953", "K242731", "K203551", "K133580", "K090590", "K052412", "K213479", "K172646", "K030061", "K152928", "K232298", "K220311", "K170130", "K092439", "K142126", "K223409", "K041605", "K200218", "K961374", "K241572", "K052202", "K024200", "K160455", "K220627", "K042053", "K173433", "K070834", "K142740", "K181415", "K221281", "K222080", "K203281", "K142243", "K190626", "K033244", 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"Interventional Fluoroscopic X-Ray System", "medical_specialty_description": "Radiology", "regulation_number": "892.1650", "device_class": "2" } } ] }