{ "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": "192244", "product_res_number": "Z-0917-2022", "event_date_initiated": "2022-02-03", "event_date_created": "2022-04-12", "recall_status": "Open, Classified", "res_event_number": "89698", "product_code": "DSA", "product_description": "MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller), Part Numbers: 300002018101, 300002018102, used with IntraSight Integrated (Part Number: 797403) IVUS systems", "code_info": "MM-TSMs with bottom protective beams", "firm_fei_number": "3008363989", "recalling_firm": "Volcano Corp", "address_1": "3721 Valley Centre Dr Ste 500 3721 Valley Centre Dr", "address_2": "Ste 500", "city": "San Diego", "state": "CA", "postal_code": "92130-3328", "additional_info_contact": "Emily Dentler\n619-380-1318", "reason_for_recall": "Multi-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They could become non-functional. Therefore, bottom protective beams will be replaced with full protective metal brackets.", "root_cause_description": "Device Design", "action": "On 02/03/22, correction notices were sent to customers who were asked to do the following:\nNotify all affected system users within the facility of this recall. The updated bracket improves protection on all sides of the MM-TSM touch screen that will prevent issues, cosmetic concerns, and maintain device integrity. If you are a distributor or have forwarded affected device(s) to another end user, it is imperative that all end-users with affected devices receive this Important Product Notice.\n\nComplete and return the customer response form.\n\nCustomers with additional questions are encouraged to contact their local recalling firm representative or customer service: Phone: 1-800-228-4728, Option 2, Email: igtd.remotesupport@philips.com, Hours of Operation: Monday - Friday 8:00AM 5:00PM PST", "product_quantity": "1358", "distribution_pattern": "US: AZ, IL, NV, MI, FL, NC, AK, PA, WI, MN, CA, AR, NJ, TX, OR, NM, SD, CO, KY, LA, DE, MA, MT, MO, VA, AL, NY, WV, SC, IN, GA, IA, OH, UT, NH, MS, TN, OK, ID, MD, HI, RI, WY, DC, WA, KS, NE, ND, CT, VT.\n\nOUS: SK, IT, DK, GB, DE, SE, IN, KW, QA, PL, NL, CL, JP, BE, AU, FR, PF, PT, NZ, CA, ES, PK, CY, AT, IL, IE, CH, GR, SA, PS, LB, HK, IS, TH, AR, OM, AE, NO, ID, RO, RS, MM, ZA, SG", "openfda": { "k_number": [ "K200674", "K954900", "K885137", "K200510", 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