{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218085", "product_res_number": "Z-1383-2026", "event_date_initiated": "2026-01-21", "event_date_posted": "2026-02-17", "recall_status": "Open, Classified", "res_event_number": "98270", "product_code": "EOQ", "k_numbers": [ "K193534", "K211493", "K243219" ], "product_description": "MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software", "code_info": "Software versions: 2.2.2, 2.2.3, 2.2.4, 2.2.5, and 4.1.1. \nUDI-DI: 10810068810803, 10810068810988.\nSerial Numbers: 110024, 120088, 120057, 120046, 120058, 120015, 120160, 120068, 120081, 120056, 110028, 120128, 120017, 120089, 120075, 110016, 120031, 120169, 120113, 120168, 120055, 120014, 120060, 120174, 120195, 120026, 110038, 120124, 120194, 110027, 110035, 120123, 120091, 120007, 110022, 120006, 120152, 120004, 120120, 120041, 120106, 110034, 120126, 120082, 120151, 120051, 120020, 120153, 120193, 120170, 120108, 120037, 120074, 120199, 120130, 120095, 110026, 120096, 120009, 120111, 120022, 120054, 120163, 110045, 120027, 110039, 120090, 120141, 120072, 120155, 110049, 120143, 110047, 120125, 120052, 110052, 120100, 120050, 120098, 120045, 120131, 110020, 110030, 110032, 110021, 120013, 120105, 120136, 120192, 110017, 120029, 120139, 110031, 120137, 120053, 110029, 120028, 120034, 120085, 120019, 120049, 120209, 120144, 120161, 120001, 110033, 120145, 120127, 110046, 110043, 120011, 120070, 120076, 120134, 120117, 110025, 120077, 120149, 120191, 120102, 120002, 120156, 120010, 120171, 120003, 120023, 120146, 120188, 120043, 120071, 120042, 120196, 110051, 120065, 120172, 120116, 120150, 120066, 120166, 120033, 110013, 120079, 120008, 120086, 120032, 120073, 1806P1, 120197, 120080, 120078, 14, 120012, 110041, 120084, 120219, 110036, 120181, 120083, 120067, 120021, 120216, 120217, 120218, 120069, 120204, 120207, 120215, 120237, 120208, 120213, 120164, 120132, 120182", "firm_fei_number": "3014447948", "recalling_firm": "Auris Health, Inc", "address_1": "5490 Great America Pkwy", "city": "Santa Clara", "state": "CA", "postal_code": "95054-3644", "reason_for_recall": "Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.", "root_cause_description": "Software design", "action": "On 1/21/2026, correction notices were emailed to customers informing them of the following: \n\nShould a MONARCH application restart occur during procedure setup, please clear the fault message and then perform a full system restart. A full system restart will prevent this issue from occurring as it will require the user to perform patient-side selection and alignment again.\n\nOnce the software update to address the issue is available, the firm will contact customers to schedule installation.\n\nComplete and return the acknowledgement form via email to MonarchSupport@its.jnj.com\n\nThis notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potential affected devices have been transferred. Please transfer this notice to other organizations on which this action has an impact. \n\nMaintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective actions.\n\nIf you have questions contact the firm at +1 (800) 434-0032 (toll-free within the United States), +1 (650) 264-6000 (Worldwide) or via email at MonarchSupport@its.jnj.com For Medical Information requests, visit firm's website at https://www.jnjmedtech.com/mir.", "product_quantity": "173", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of MN, FL, NJ, NY, VA, WI, AZ, AL, MS, LA, MI, MA, MT, PA, WV, GA, DE, TX, CA, OH, IN, SC, CT, ND, MO, DC, IL, NE, ID, WA, NC, TN, OR, CO, SD, NM, VT, MD and the countries of Hong Kong, China, Canada.", "openfda": { "k_number": [ "K223836", "K173760", "K944649", "K121035", "K243497", "K192367", "K962555", "K183256", "K944976", "K832449", "K152466", "K822180", "K231970", "K990547", "K854414", "K211493", 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