{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "210365", "product_res_number": "Z-0291-2025", "event_date_initiated": "2024-10-07", "event_date_posted": "2024-11-13", "recall_status": "Open, Classified", "res_event_number": "95486", "product_code": "CBK", "k_numbers": [ "K181166" ], "product_description": "Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B.\n\nIntended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.", "code_info": "Model Number (UDI-DI Number): AU2110X15B (606959051980); BL2110X15B (606959055520); BR2110X18B (606959055476); CA2110X12B (606959052307); DE2110X13B (606959054110); DS2110X11B (606959051942); EE2110X15B (606959055544); ES2110X15B (606959054080); EU2110X15B (606959054981); EU2110X19 (606959055537); FP2110X10 (606959062092); FR2110X14B (606959055506); GB2110X15B (606959054127); IA2110X15B (606959055490); IN2110X15B (606959051959); IT2110X21B (606959055421); JP2110X16B (606959051973); KR2110X15B (606959055483); LA2110X15B (606959055452); ND2110X15B (606959055513); PP2110X10 (606959054035); RBRBR2110X18B (606959055476); RDS2110X11B (606959060517); TR2110X15B (606959055551); UDS2110X11B (606959060500). All Serial Numbers.", "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": "Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.", "root_cause_description": "Device Design", "action": "An URGENT Medical Device Correction notification was mailed to consignees on 10/07/2024. The notification provides instructions to users to prevent risks for patients when using in-line nebulizers and a set FiO2. Consignees are to distribute the provided notification to all members of their organization responsible for setting up and supervising patients who use these devices. Additionally, if affected devices were further distributed the notification needs to be provided to them. Philips Respironics is currently investigating the issue and plans to follow-up communications to customers to provide additional guidance and solutions at a later date. \n\nConsignees with any questions can contact their local Philips Respironics Customers Service at: \n\nFor DME and Homecare Customers: 1-800-345-6443, option 4, option 5\nFor Hospital Customers: 1-800-722-9377, option 2. \n\nOn 12/27/2024, Philips Respironics sent an updated letter to consignees. It included additional guidance to customers. Dependent upon the scenarios described, customers will be instructed to either contact one of the options provided in the Urgent Medical Device Correction letter for servicing of their device to replace the flow sensor or continue use of the device in accordance with the guidance provided in the Urgent Medical Device Correction letter. Execution of flow sensor replacement will take place through a Field Change Order (FCO).\n\nAn 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 ve", "product_quantity": "82,800 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.", "openfda": { "k_number": [ "K922705", "K822456", "K813253", "K051767", "K841757", "K060549", "K222024", "K802583", "K993449", "K002881", "K802051", "K894322", "K792455", "K801890", "K112754", "K051895", "K062793", "K120639", "K123149", "K103803", "K020746", "K844179", "K923809", "K851509", "K023366", "K896735", "K040540", "K042468", "K853300", "K192307", "K010925", "K823861", "K896269", "K241520", "K862025", "K023350", 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