Volcano Corporation Recall: SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with
Volcano Corporation Recall: SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Volcano Corporation; Product: SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x; Reason for recall: If FFR meas
| Recalling firm | Volcano Corporation |
|---|---|
| Product | SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| 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, |
| Recall initiated | 20220119 |
| Recall number | Z-0885-2022 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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