{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214817", "product_res_number": "Z-2175-2025", "event_date_initiated": "2025-05-30", "event_date_posted": "2025-07-25", "recall_status": "Open, Classified", "res_event_number": "97197", "product_code": "MHX", "k_numbers": [ "K201746" ], "product_description": "Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R", "code_info": "REF/UDI-DI:\n00-1007-R/05060472440013, 05060472442918;\n00-1024-R/05060472441027, 05060472442925;\n00-1026-R/05060472441058, 05060472442932.\n\nSoftware Version: vx.28", "firm_fei_number": "3003832357", "recalling_firm": "Remote Diagnostic Technologies Ltd.", "address_1": "Farnborough Aerospace Centre Aerospace Boulevard", "city": "Farnborough", "country": "United Kingdom", "additional_info_contact": "Philips Customer Services\n800-7229377", "reason_for_recall": "Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.", "root_cause_description": "Software change control", "action": "On 5/30/3035, Philips mailed field safety notices to customers and distributors who were informed of the following: \n\nReverting to the outdated software version reintroduces the video laryngoscope issue previously corrected in FSN-2023-CC-EC-005 (Unexpected Device Error When Used with Tempus Pro Video Laryngoscope).\n\nCustomers were asked to do the following:\n1) Dispose of USB Flash Drive.\n2) Ensure monitor is on Software version vx.34 or higher.\n4) If your device(s) is on a software version below vx.34, contact firm representative for software update instructions.\n5) Complete and return response form via email to ECR.Recall.Response@Philips.com\n\nIn addition, distributors were asked to do the following:\n1) Modify the correction response form and substitute your firm's email and fax information.\nSend a copy of the correction notice and modified response form to each customer to whom you distribute the affected product.\n\nIf you need any further information or support contact firm at (800) 722-9377 or email ECR.Recall.Response@Philips.com", "product_quantity": "55", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of SC, KY, NV, IA, MI and the country of GB.", "openfda": { "k_number": [ "K213181", "K002209", "K131829", "K950264", "K213799", "K173036", "K200494", "K122146", "K031781", "K192137", "K131223", "K132026", "K113054", "K922210", "K080495", "K003621", "K203435", "K031124", "K132077", "K133576", "K033964", "K092970", "K221056", "K153707", "K200859", "K990068", "K131414", "K082785", "K083271", "K012226", "K062576", "K113623", "K192514", "K202405", "K102040", "K173768", "K131032", "K030038", "K122253", "K202336", "K982279", "K062271", "K100040", "K240320", "K061052", "K061185", "K030931", "K141811", "K180482", "K221348", "K131929", "K053522", "K061675", "K121367", "K992273", "K150329", "K133222", "K001348", "K023698", "K060281", "K924575", "K062324", "K070791", "K181831", "K872476", "K182979", "K230604", 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