Z-0885-2022Class II

SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x

Name: Z-0885-2022 SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Creator: Volcano Corporation
Published: 2022-01-19
License: https://open.fda.gov/license/

Volcano Corporation / initiated 2022-01-19 / Open, Classified / root cause: design

FDA source

Volcano Corporation began a recall of SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x on 2022-01-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0885-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-19
Posted: 2022-04-06
Recalling firm: Volcano Corporation
Product: SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Product code: OWB Interventional Fluoroscopic X-Ray System
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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, [email protected] Hours of Operation: Monday - Friday 8:00AM - 5:00PM PST
Quantity in commerce: 3,216
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0885-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0885-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-04-13	2022-04-06

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)