FDA-Device2022-04-13Class II
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Volcano Corporation
Hazard
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.
Sold states
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 OUS: 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
Affected count
3,216
Manufactured in
2451 Mercantile Dr, Rancho Cordova, CA, United States
Products
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0885-2022Don't want to check this manually?
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