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Volcano Corporation Recall 89673

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

Volcano Corporation Recall 89673 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0885-2022
Event ID89673
Event DescriptionSyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software version 4.2.x
Product TypeDevices
DistributionUS: 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
Recall ReasonIf 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.
Device Classification20220413
Device Code InfoAll 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
Center Classification Date20220406
Recall Initiation Date20220119
Recalling FirmVolcano Corporation
Initial Notification Letter
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