{ "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": 4 } }, "results": [ { "cfres_id": "219014", "product_res_number": "Z-1614-2026", "event_date_initiated": "2026-03-02", "event_date_posted": "2026-03-26", "recall_status": "Open, Classified", "res_event_number": "98537", "product_code": "CBK", "k_numbers": [ "K181166" ], "product_description": "Philips Respironics Trilogy Evo, Software Version 1.05.15.00. Continuous home-use ventilator device.", "code_info": "All Model No.; All UDI; All Serial No.", "firm_fei_number": "2518422", "recalling_firm": "Philips Respironics, Inc.", "address_1": "1001 Murry Ridge Ln", "city": "Murrysville", "state": "PA", "postal_code": "15668-8517", "additional_info_contact": "Philips Customer Service \n1-800-345-6443", "reason_for_recall": "Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.", "root_cause_description": "Under Investigation by firm", "action": "An UPDATED: \"URGENT FIELD SAFETY NOTICE\" dated 3/2/26 was mailed to consignees containing recall information for three different failure modes that can be experienced in all Trilogy Evo, Trilogy EVO O2, Trilogy Evo Universal, and Trilogy EV300 devices. The firm identified that using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. This can lead to under-delivery of therapy to the patient. Consignees are being instructed to update all devices with software version 1.05.15.00 through the My Philips for Professionals and In Center websites. The provided Appendix B contains the required instructions. Consignees are also instructed to review the latest version of the User Manual Addendum, communicate the safety notice to all in their organization who interact with affect devices, and forward the notice to those who received product that was further distributed. Consignees are to stop all use of non-pneumatic nebulizers, including vibrating mesh nebulizers, with all affected devices. Distributors should notify their customers of this recall with the provided notice and response form. DME and Homecare Customers can contact 1-800-345-6443 (option 2, option 1) for assistance. Hospital Customers can contact 1-800-722-9377 (option 2) for assistance.", "product_quantity": "113,717 units", "distribution_pattern": "Worldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: Argentina, Austria, Australia, Bosnia and Herzegovina, Bangladesh, Belgium, Bulgaria, Bolivia, Brazil, Bahamas, Canada, Switzerland, Chile, China, Colombia, Czech Republic, Germany, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Georgia, French Guiana, Gibraltar, Greece, Guatemala, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Italy, Jersey, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Lithuania, Morocco, Montenegro, North Macedonia, Myanmar, Martinique, Malta, Mexico, Malaysia, Nigeria, Netherlands, Norway, Nepal, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, Portugal, Paraguay, Qatar, R¿union, Romania, Serbia, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Turkey, Taiwan, Ukraine, United Arab Emirates, United Kingdom, Vietnam, Mayotte, South Africa, Zimbabwe.", "openfda": { "k_number": [ "K841757", "K010317", "K842362", "K050860", "K130171", "K870275", "K032922", "K193056", "K871448", "K083526", "K072885", "K023350", "K922975", "K983981", "K801890", "K010925", "K802270", "K040790", "K222644", "K926292", "K102120", "K113743", "K970839", "K010093", "K950484", "K820393", "K823858", "K915488", "K830230", "K840865", "K911450", "K982580", "K133868", "K901785", "K990429", "K781926", "K021112", "K122438", "K772065", "K862212", "K770132", "K051767", "K851509", "K202970", "K022132", "K241135", "K992608", "K070513", "K981971", "K801697", "K083122", "K251888", "K903010", "K023289", "K013642", "K880054", "K092135", "K122560", "K841818", "K870861", "K921821", "K103803", "K051222", "K872113", "K984577", "K993167", "K780188", "K790732", "K110083", "K902859", "K905234", "K041223", "K933262", "K790733", "K812958", "K092648", "K923992", "K884793", "K952880", 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