Recall Z-0885-2022— Volcano Corporation
Class II · Ongoing
Class II FDA medical device recall by Volcano Corporation, initiated 2022-01-19. It names 5 FDA 510(k) clearances: K190626, K172574, K161756 and 2 more. Product: SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x. 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..
- Recalling firm
- Volcano Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-01-19
- Firm location
- Rancho Cordova, CA, United States
510(k) clearances named in this recall
5 on FDA's record- K190626 — SyncVision System
- K172574 — SyncVision System
- K161756 — SyncVision System
- K151904 — SyncVision System
- K132558 — SYNC-RX SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.