# FDA recall Z-0885-2022

> **Volcano Corporation** · Class II · device recall initiated 2022-01-19.

## 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.

## 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, 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

## Key facts

- **Recall number:** Z-0885-2022
- **Recalling firm:** Volcano Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-19
- **Report date:** 2022-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rancho Cordova, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0885-2022

## Citation

> AI Analytics. FDA recall Z-0885-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0885-2022. Source: US FDA. Licensed CC0.

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