Volcano Corporation recalls SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

Recall date

January 19, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0885-2022

FDA classification

Class II

Brand / firm

Volcano Corporation

Sold / distributed

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,…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x