{ "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": "192436", "product_res_number": "Z-0926-2022", "event_date_initiated": "2022-02-07", "event_date_created": "2022-04-13", "recall_status": "Open, Classified", "res_event_number": "89791", "product_code": "FFL", "k_numbers": [ "K962070" ], "product_description": "The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following product model #s: 21075A, 21076A, 21078A, 989803162621, 989803162631, 989803162641.", "code_info": "All lots manufactured IFUs from 2008 to present. UDI for probe model 21075A\t(01)00884838000995, model 21076A\t(01)00884838001008, model 21078A\t(01)00884838001015, model 989803162621\t(01)00884838008045, model 989803162631\t(01)00884838008052, and model 989803162641\t(01) 00884838008069", "firm_fei_number": "1218950", "recalling_firm": "Philips North America, LLC", "address_1": "3000 Minuteman Rd", "city": "Andover", "state": "MA", "postal_code": "01810-1032", "additional_info_contact": "Philips Customer Services\n800-7229377", "reason_for_recall": "Update to instructions for use regarding the cleaning and disinfection process for the reusable probes.", "root_cause_description": "Device Design", "action": "The firm, Philips, issued \"URGENT Medical Device Recall\" Customer notification letters on 07 Feb 2022 via certified mail. \nActions planned by the firm: An IFU addendum (part# 453564978601) was created that provides updated instructions for cleaning, disinfection, and sterilization. This addendum is to be downloaded www.philips.com/ifu and kept with the main IFU (part# 453564635891). \nCustomer should take the following actions to prevent risk to patients or users: Prepare and soak in an enzymatic solution (detergent) to remove any debris prior to disinfection or sterilization. To reduce risk of cross-infection always clean all probes before applying to a different patient. Esophageal/Rectal Probes must be cleaned and sterilized between patient use. Skin probes can be cleaned and disinfected or cleaned and sterilized between patient use.\n\nContact Philips Customer Services with questions. US customers: 1 (800) 722-9377, Worldwide customers: Contact local Philips representative.", "product_quantity": "478,931 units", "distribution_pattern": "Worldwide distribution: US (nationwide) Including Puerto Rico and OUS (foreign) countries including: Afghanistan, Albania, Algeria, Angola, Argentina, Aruba, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Burundi, Cambodia, Canada, Chile, China, Columbia, Congo (Democratic Republic of the), Costa Rica, Cote D'lvoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, French Polynesia, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Japan, Jordan, Kazakhstan, Korea Republic of, Kuwait, Lao People's Democratic Republic, Latvia, Lebanon, Liberia, Libya, Lithuania, Luxembourg, Macao, Macedonia, Malaysia, Maldives, Mali, Malta, Mauritius, Mayotte, Mexico, Moldova, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antilles, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Qatar, Reunion, Romania, Russian Federation, Rwanda, Saint Lucia, Saint Pierre and Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Suriname, Swaziland, Sweden, Switzerland, Syrian and Republic, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen and Zambia.", "openfda": { "k_number": [ "K792344", "K052048", "K860268", "K934675", "K860946", "K914505", "K851965", "K870615", "K870696", "K934636", "K921233", "K871779", "K862729", "K863081", "K924027", "K972091", "K922678", "K954377", "K951532", "K896169", "K933260", "K961248", "K800608", "K930349", "K172299", "K860269", "K935737", "K831875", "K841942", "K851922", "K900269", "K922114", "K850954", "K891254", "K896992", "K854652", "K102887", "K951761", "K190492", "K012581", "K864874", "K082803", "K860270", "K962387", "K935721", "K955049", "K910603", "K884738", "K871777", "K811580", "K861469", "K970489" ], "device_name": "Dislodger, Stone, Basket, Ureteral, Metal", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4680", "device_class": "2", "registration_number": [ "1825146", "1018233", "3005987240", "8010047", "3023460764", "9611031", "3010399422", "3012649202", "9681442", "3006174295", "2243757", "1644312", "3010138349", "1047843", "3011193403", "9611590", "3035480112", "3017425975", "3008808042", "3038296436", "3006082230", "3021023752", "2640138", "3008048800", "3007092328", "3020746799", "3013530345", "3017262662", "3007738736", "1651252", "3009039068", "3018116884", "3002807314", "3012494290", "3041276591", "3022764278", "3031158", "3014279513", "3011707784", "3016931915", "1928237", "3030447506", "3007695959", "3007055279", "3004365956", "3011137372", "1222168", "3010303097", "3016096097", "1058584", "3013460719", "1319660", "1000393132", "3033848208", "1519132", "9617744", "3002504068", "3010400865", "1828132", "3012797688", "3030511423", "3007156625", "3009607734", "9610711", "3004361445", "3013526170", "3010273872", "2020550", "3030504644", "3004083736", "3007305624", "9611102", "1000121056", "1061124", "1313046", "3010011359", "3003289691", "3014615697", "9612074", "3011050570", "3010202439", "3005099803", "8010418", "3030733800", "1037905", "3014342096", "3016696686", "3017210488", "3010035831", "1820334", "3003832357", "9610617", "3013557562", "2124215", "3032436880", "3017103427", "9680718", "3004134316", "2183873", "3008573567", "3043337628", "3005465238", "3005941719", "3014769442", "3018762668" ], "fei_number": [ "1825146", "1018233", "3005987240", "3023460764", "3000215024", "3007475226", "3010399422", "3012649202", "3008133910", "3002770040", "3006174295", "2243757", "3010138349", "1047843", "3011193403", "3035480112", "3008808042", "3038296436", "3006082230", "3021023752", "3008048800", "3007092328", "3020746799", "3013530345", "1000512168", "3017262662", "3007738736", "3009039068", "3018116884", "3002807314", "3012494290", "3041276591", "3022764278", "3014279513", "3011707784", "3002808268", "3016931915", "1928237", "3003370911", "3030447506", "3002807019", "3002807072", "1000237915", "3006279007", "3007695959", "3007055279", "3004365956", "1000136478", "1222168", "3010303097", "3016096097", "3000280067", "3002806368", "1000219637", "3014447948", "3013460719", "3005747797", "3033848208", "1000393132", "1519132", "3002504068", "3010400865", "1828132", "3012797688", "3007130719", "3030511423", "3009607734", "3004361445", "3013526170", "3010273872", "2020550", "3030504644", "3004083736", "3002807795", "3007305624", "1000121056", "1313046", "3010011359", "3003289691", "3002807917", "3014615697", "3002807111", "3011050570", "3005099803", "3030733800", "3002808001", "1037905", "3014342096", "3016696686", "3017210488", "3010035831", "1820334", "3003832357", "3013557562", "2124215", "3032436880", "3017103427", "3004134316", "1000117748", "2183873", "3008573567", "3043337628", "3005465238", "3014769442", "3018762668" ] } } ] }