{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216707", "product_res_number": "Z-0883-2026", "event_date_initiated": "2025-10-31", "event_date_posted": "2025-12-04", "recall_status": "Open, Classified", "res_event_number": "97843", "product_code": "IYN", "k_numbers": [ "K203406", "K223771", "K232500", "K242519", "K242670" ], "product_description": "Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841,", "code_info": "UDI:700884838103405,\n00884838120266,\n00884838064713,\n00884838108455\n/ Serial Numbers: 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"firm_fei_number": "3019216", "recalling_firm": "Philips Ultrasound, LLC", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Philips Customer Care Solutions Center\n425-487-8092", "reason_for_recall": "Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining.", "root_cause_description": "Software design", "action": "On November 1, 2025, Philips issues an Urgent Medical Device Recall (Correction) Notification to affected consignees. Phillips ask consignees to take the following actions:\n\n1. Utilize an Android based device with your Lumify system.\n\n2. Lightning port devices are not affected and may continue to be used as normal.\n3. If you use an 05 based device, do not update your OS device to software version lax.\n4. Turn off 05 auto-updates on USB host devices for Lumify by following the below steps:\n5. Place this Notice with the documentation of the affected Ultrasound system(s); ensure the notice is in a place likely to be viewed by device operators.\n6. Circulate this Notice to all users of the affected device(s) so that they are aware of the issue.\n7. Complete the Acknowledgment form indicating you have read and understand the recall.", "product_quantity": "4,819 systems", "distribution_pattern": "Worldwide US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, PR and the countries of Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Dominican Rep, Ecuador, El Salvador, Estonia, France, Germany, Greece, Guatemala, Honduras\t, Hungary, Iceland, India, Indonesia, Israel, \tItaly, Jordan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Singapore, Slovakia, South Africa, South Korea, Spain, St. Pier/Miquel., Sweden, Switzerland, Taiwan, Thailand, Trinidad/Tobago, Tunisia, T¿rkiye, United Kingdom, Uruguay, Vietnam.", "openfda": { "k_number": [ "K152309", "K891238", "K062247", "K141261", "K152195", "K180374", "K152165", "K162187", "K840953", "K103649", "K040596", "K253716", "K133431", "K181637", "K001711", "K090229", "K052042", "K172129", "K162549", "K123610", "K150002", "K073408", "K112122", "K242223", "K143089", "K171048", "K253597", "K802254", "K130801", "K173957", "K173486", "K251985", "K101312", "K200708", "K101878", "K153421", "K091009", "K010631", "K053084", "K813544", "K033139", "K200449", "K160807", "K241201", "K113690", "K211746", "K992663", "K152543", "K233195", "K840402", "K222198", "K872817", "K842055", "K002470", "K251192", "K130659", "K131267", "K160162", "K233734", "K260846", "K220269", "K172993", "K200585", "K211597", "K220358", "K113663", "K150045", "K172607", "K210154", "K250214", "K022858", "K051308", "K142876", "K043588", "K080548", "K031066", "K100931", "K994096", "K141675", "K102023", "K141639", "K141459", "K200851", "K161843", "K243299", 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