SyncVision Systems — Class II medical device recall Z-0885-2022
Ongoing recall by Volcano Corporation, reported 2022-04-13, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, th
| Recall number | Z-0885-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corporation, Rancho Cordova, CA, United States |
| Recall initiated | 2022-01-19 |
| Classified | 2022-04-06 |
| Reported by FDA | 2022-04-13 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, WA, WI, WV |
| Quantity | 3,216 |
| UPC / GTIN / UDI-DI | 00845225012434 |
| Model numbers | 30000485688X, 400-0100.10 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0885-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.