Volcano Corporation SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Brand
Volcano Corporation
Lot Codes / Batch Numbers
All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x
Products Sold
All serial numbers, limited to cases when: The SyncVision runs the current supported software version 4.2.x, AND The secondary modality (IntraSight IVUS) runs software version 5.x. Device Identifier (DI): 00845225012434
Volcano Corporation is recalling SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x due to 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-. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 measurement(s) were performed within the same procedural session, the user needs to follow any one of the following steps just prior to the iFR/FFR pullback to mitigate the issue: - Click on the "iFR Spot" button on the IntraSight system and perform at least one iFR Spot measurement. OR: - Go back to the "case menu" on the system and then re-enter the LIVE screen to perform iFR pullback. OR: - Exit the procedure and then re-enter the procedure using "Continue Procedure" option. Philips is in the process of updating the Operators Manual to ensure the issue, mitigations, and workarounds are effectively highlighted to inform the user. Notify all system users within your facility of this communication and retain a copy for reference. Send a copy of this notification to any customer to whom you have distributed the affected product to. Customers requiring additional information can contact customer service: 1-800-228-4728, Option 2, igtd.remotesupport@philips.com Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, DC, PR
Page updated: Jan 10, 2026