SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Summary
The FDA issued a Class II for SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version by Volcano Corporation. 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-.
Details
Source
Device Recall
External ID
Z-0885-2022
Action Date
2022-04-13
Status
Ongoing
Category
device
Product Description
SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Lot/Code Info: 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
Quantity Affected: 3,216
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-01-19
Company
Rancho Cordova, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 149 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Volcano Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Volcano Corporation have FDA actions?
This is the only FDA action we have on record for Volcano Corporation in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0885-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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