{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "192180", "product_res_number": "Z-0885-2022", "event_date_initiated": "2022-01-19", "event_date_created": "2022-04-06", "recall_status": "Open, Classified", "res_event_number": "89673", "product_code": "OWB", "k_numbers": [ "K132558", "K151904", "K161756", "K172574", "K190626" ], "product_description": "SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x", "code_info": "All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x. Device Identifier (DI): 00845225012434", "firm_fei_number": "2939520", "recalling_firm": "Volcano Corporation", "address_1": "2451 Mercantile Dr", "city": "Rancho Cordova", "state": "CA", "postal_code": "95742-6326", "additional_info_contact": "Emily Dentler\n916-281-2900", "reason_for_recall": "If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR Co-Registration results to be displayed, that may cause users to mistakenly use incorrect measurements, leading to inappropriate patient treatment. Image acquisition and processing system operators manual to be updated to include workflow alternatives.", "root_cause_description": "Device Design", "action": "On 01/19/22, correction notices were sent to customers who were informed of the following:\n\nIf FFR measurement(s) are made prior to an iFR/FFR co-registration in the same procedural session. The user will be visually alerted with a warning message \"Insufficient data, distal segment is not co-registered\" on the display about the distal segment not being co-registered. The user may also notice the initial iFR/FFR co-registered distal value(s) will be higher than the correctly displayed distal iFR/FFR value(s).\n\nRecommended Course of Action:\nIf prior to the iFR/FFR Pullback on the system, FFR measurement(s) were performed within the same procedural session, the user needs to follow any one of the following steps just prior to the iFR/FFR pullback to mitigate the issue:\n\n- Click on the \"iFR Spot\" button on the IntraSight system and perform at least one iFR Spot measurement.\nOR:\n- Go back to the \"case menu\" on the system and then re-enter the LIVE screen to perform iFR pullback.\nOR:\n- Exit the procedure and then re-enter the procedure using \"Continue Procedure\" option.\n\nPhilips is in the process of updating the Operators Manual to ensure the issue, mitigations, and workarounds are effectively highlighted to inform the user. Notify all system users within your facility of this communication and retain a copy for reference. Send a copy of this notification to any customer to whom you have distributed the affected product to. \n\nCustomers requiring additional information can contact customer service: 1-800-228-4728, Option 2, igtd.remotesupport@philips.com Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST", "product_quantity": "3,216", "distribution_pattern": "US: WI, CA, CO, MO, ID, DC, LA, VA, KS, OK, GA, KY, IL, AZ, NY, IN, FL, TX, NC, OH, WA, OR, NM, MT, IA, MI, TN, MN, PA, AL, MA, WV, NV, NH, CT, NE, NJ, HI, AR, UT, MD, SC, MS, AK, DE\n\nOUS: JP, SA, GB, DE, PT, SG, PL, ZA, NL, MT, ES, IN, GR, EG, FI, HK, FR, NO, DK, BE, AT, IT, CO, KW, MX, PS, QA, CY, CA, TW, LV, SE, HR, SI, MY, KR, IL, TH, AU, BR, CL, SK, CH, LB, OM, ID, PK, IE, NZ, PR, RO, MM, AR, RS, RU, PA, KE, UZ", "openfda": { "k_number": [ "K231692", "K183109", "K251523", "K210900", "K171829", "K232344", "K021049", "K032761", "K240199", "K051064", "K212523", "K092004", "K200917", "K133278", "K202547", "K220946", "K173736", "K181550", 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