{ "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": "2026-10-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "202483", "product_res_number": "Z-2517-2023", "event_date_initiated": "2023-06-30", "event_date_posted": "2023-09-06", "recall_status": "Completed", "res_event_number": "92761", "product_code": "ITX", "k_numbers": [ "K042540", "K043535", "K081661", "K132304", "K222648", "K120321" ], "product_description": "3D9-3v Transducer, accessory to Philips Ultrasound Systems: EPIQ Elite; Affiniti 30, 50, and 70; ClearVue 850; HD15; iU22; and Compact 5000", "code_info": "UDI-DI:00884838061545, Serial Numbers: F07VBZ, F083JP, F086Z5, F088QC, F08JPF, F08K4H, F08VLP, F08VLY, F08W1C, F08W1D, F08W1J, F08W1K, F08W1L, F08W1M, F08W1Q, F08WXP, F08WXY, F08WZY, F08X01, F08X02, F08X03, F08X04, F08Y2T, F08ZR3, F08ZR4, F08ZR5, 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F09BTF, F09BTJ, F09BTK, F09C1K, F09F46, F09JT1, F09VH8, F0B7NL, F0B7NP, F0B7NR, F0B7NW, F0B7P2, F0B9ZZ, F0BB00, F0BBGV, F0BCFL, F0BCFN, F0BCFP, F0BDMW, F0BDMX, F0BFKD, F0BFXL, F0BFXP, F0BFXT, F0BFXW, F0BHZQ, F0BHZY, F0BJ9Z, F0BJYV, F0BMC3, B0T4K4, B2JDYH, B2PWBT, B2RL1T, B35JLT, B3TCYD, F01X0Z, F04TQ8, F05QVR, F06WH6, F07D6C, F09V2B, F0B7XB, F0B7XF, F0B8G6, F0B95B, F0B95C, F0BFK7", "firm_fei_number": "3019216", "recalling_firm": "Philips Ultrasound, Inc.", "address_1": "22100 Bothell Everett Hwy", "city": "Bothell", "state": "WA", "postal_code": "98021-8431", "additional_info_contact": "Philips Customer Care Solutions Center\n800-722-9377", "reason_for_recall": "Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.", "root_cause_description": "Process control", "action": "On 6/30/23, recall notices were sent to customers who were advised to do the following:\n\n1) Stop usage and/or distribution of affected transducers and secure them in a location where they cannot inadvertently be used.\n2) Circulate the notice to all users of this device so that they are aware of the issue. Retain this notice with your system(s) and ensure the letter is in a place likely to be seen/viewed.\n3) Complete and return the response form via email to: ultrasound.corrections@philips.com\n\nField Service Engineers will visit your site to provide a replacement device, and collect the affected product.\n\nContact Customer Care Solutions Center if you need further information or support concerning this issue at 1-800-722-9377.\n\nOn 7/24/23 additional recall notices were distributed to customers informing them that additional devices were found to be affected.", "product_quantity": "449", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of FL, MN, AZ, NC, CA, MO, OH, WV, AL, NH, IN, IL, VT, PA, NY, NE, TX, WI, MI, KY, NV, MA, SD, LA, CO, TN, AK, GA, WA, UT, NM, ME, AR, SC and the countries of Italy, China, Netherlands, New Zealand, Hungary, Australia, France, Thailand, C¿te D'Ivoire, Germany, Canada, Mexico, Spain, Saudi Arabia, Uzbekistan, Greece, Yemen.", "openfda": { "k_number": [ "K990175", "K092637", "K061153", "K935994", "K250762", "K920307", "K013170", "K910966", "K073623", "K041818", "K992305", "K854788", "K910669", "K013363", "K874860", "K101829", "K001016", "K850422", "K870038", "K944610", "K120156", "K833224", "K060879", "K812301", "K852947", "K843247", "K070195", "K982610", "K963169", "K090465", "K894763", "K233965", "K944287", "K141093", "K942296", "K103722", "K971397", "K945320", "K140854", "K991236", "K983691", "K083877", "K953819", "K854785", "K910850", "K002784", "K992178", "K982733", "K921147", "K101952", "K091828", "K121807", "K974301", "K152126", "K851240", "K913890", "K871432", "K911116", "K070515", "K042445", "K072918", "K911043", "K903984", "K041638", "K013723", "K941935", "K944017", "K012522", "K061560", "K970514", "K854337", "K911309", "K080555", "K992152", "K261170", "K142618", "K973622", "K911435", "K860361", "K863708", "K925486", "K072266", "K002856", "K974544", "K853966", "K022860", "K980091", 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