Recall Z-0885-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Volcano Corporation
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
| Date | Jan 19, 2022 |
| Status | Open, Classified |
| Reason | 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 | Device Design |
| Action | On 01/19/22, correction notices were sent to customers who were informed of the following: If 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). Recommended Course of Action: If prior to the iFR/FFR Pullback on the system, FFR mea |
| Quantity | 3,216 |
| Distribution | 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, |
| FDA record | Open on fda.gov |